DDrare: Database of Drug Development for Rare Diseases

13. 多発性硬化症／視神経脊髄炎
［臨床試験数：3,050，薬物数：2,147（DrugBank：348），標的遺伝子数：244，標的パスウェイ数：228］

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	NCT04601142 (ClinicalTrials.gov)	October 31, 2020	15/10/2020	Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism	Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study	Glucocorticoid Resistance;Gene;Neuromyelitis Optica	Drug: Methylprednisolone	Beijing Tongren Hospital	NULL	Recruiting	16 Years	80 Years	All	350		China
2	EUCTR2019-004980-36-LT (EUCTR)	22/10/2020	25/05/2020	Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis	A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2)	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE	Merck Healthcare KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	930	Phase 3	Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Latvia;Kuwait;Tunisia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
3	EUCTR2020-000647-30-LT (EUCTR)	22/10/2020	14/09/2020	Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)	A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES	Non-relapsing 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan
4	NCT04480853 (ClinicalTrials.gov)	October 12, 2020	17/7/2020	Safety and Efficacy Study of Fingolimod in Taiwanese Adults (= 20years) With Relapsing Remitting Multiple Sclerosis	A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)	Multiple Sclerosis	Drug: Fingolimod	Novartis Pharmaceuticals	NULL	Recruiting	20 Years	N/A	All	30	Phase 4	Taiwan
5	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
No.	TrialID	Date_ enrollment	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	NCT04203498 (ClinicalTrials.gov)	October 1, 2020	17/12/2019	Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis	A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients With Spasticity Due to Multiple Sclerosis	Multiple Sclerosis (MS)	Drug: Nabiximols;Drug: Placebo	GW Pharmaceuticals Ltd.	NULL	Recruiting	18 Years	N/A	All	446	Phase 3	Poland
7	EUCTR2020-000647-30-DE (EUCTR)	16/09/2020	29/06/2020	Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)	A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES	Non-relapsing 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan;United States;Belarus
8	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
9	EUCTR2019-004980-36-SK (EUCTR)	31/07/2020	27/05/2020	Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis	A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2)	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE	Merck Healthcare KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	930	Phase 3	Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Kuwait;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
10	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
No.	TrialID	Date_ enrollment	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	EUCTR2018-000620-34-DE (EUCTR)	06/05/2020	08/11/2019	Imatinib treatment for Multiple Sclerosis (MS) Relapses	Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS	Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	INN or Proposed INN: IMATINIB MESILATE INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Department of Clinical Neuroscience, Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	Germany;Sweden
12	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
13	EUCTR2019-001341-40-BE (EUCTR)	29/04/2020	17/03/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: 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
14	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
15	EUCTR2019-002625-29-GB (EUCTR)	16/03/2020	18/06/2020	A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis	A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis - Study in MS patient Naïve to treatment with Nabiximols	Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Sativex Oromucosal Spray Product Name: Sativex Oromucosal Spray INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL	GW Pharma Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	52	Phase 3	Poland;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
16	EUCTR2019-002625-29-PL (EUCTR)	14/01/2020	21/11/2019	A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis	A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis	Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Sativex Oromucosal Spray Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL	GW Pharma Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	52	Phase 3	Poland;United Kingdom
17	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
18	NCT04115488 (ClinicalTrials.gov)	October 1, 2019	10/9/2019	Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®	Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)	Relapsing-Remitting Multiple Sclerosis (RRMS)	Biological: Intravenous (IV) infusions	Polpharma Biologics S.A.	NULL	Active, not recruiting	18 Years	60 Years	All	260	Phase 3	Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine
19	EUCTR2018-004751-20-HR (EUCTR)	18/09/2019	02/12/2019	A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis	Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope	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]	Product Code: PB006 INN or Proposed INN: NATALIZUMAB Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB	Polpharma Biologics S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 3	Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
20	EUCTR2018-004751-20-PL (EUCTR)	22/07/2019	25/04/2019	A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis	Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope	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]	Product Code: PB006 INN or Proposed INN: NATALIZUMAB Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB	Polpharma Biologics S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 3	Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, 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
21	NCT03983252 (ClinicalTrials.gov)	July 2019	31/5/2019	Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis	Effect of Alemtuzumab on Microglial Activation Assessed Using Novel [F-18]-Based Positron Emission Tomography (PET) Ligand in Multiple Sclerosis	Multiple Sclerosis	Drug: [F-18]PBR06	Brigham and Women's Hospital	Genzyme, a Sanofi Company	Not yet recruiting	18 Years	60 Years	All	10	Phase 1;Phase 2	United States
22	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
23	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
24	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
25	EUCTR2012-000541-12-HR (EUCTR)	23/04/2019	17/05/2019	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Portugal;Greece;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Australia;Denmark;Bulgaria;Germany
No.	TrialID	Date_ enrollment	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	NCT04408742 (ClinicalTrials.gov)	April 15, 2019	26/5/2020	Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple Sclerosis	The Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple Sclerosis	Multiple Sclerosis;Menstrual Pain;Anxiety;Fatigue;Neurologic Symptoms	Other: pain;Other: fatigue;Other: anxiety;Other: position sense;Other: balance;Other: dual task performance	Ankara Yildirim Beyazit University	NULL	Completed	26 Years	49 Years	Female	14		Turkey
27	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
28	NCT04286828 (ClinicalTrials.gov)	March 25, 2019	23/2/2020	Position Sense, Balance, and Dual Task Performance at the Menstrual Cycle in Females With Multiple Sclerosis	An Investigation of Knee Position Sense, Balance, and Dual Task Performance in Different Phases of Menstrual Cycle in Females With Multiple Sclerosis	Multiple Sclerosis;Neurologic Symptoms;Menstrual Cycle	Other: Position Sense;Other: Balance;Other: Dual Task Performance	Ankara Yildirim Beyazit University	NULL	Completed	26 Years	49 Years	Female	27		Turkey
29	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
30	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
No.	TrialID	Date_ enrollment	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	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
32	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
33	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
34	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
35	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
No.	TrialID	Date_ enrollment	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	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
37	EUCTR2018-001896-19-BG (EUCTR)	17/12/2018	11/10/2018	Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS)	Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS	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: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	Poland;Ukraine;Romania;Bulgaria
38	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
39	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
40	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
No.	TrialID	Date_ enrollment	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	EUCTR2017-002632-17-GB (EUCTR)	25/07/2018	06/02/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mavenclad ® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Netherlands;Sweden;United Kingdom
42	EUCTR2016-004719-10-FI (EUCTR)	25/07/2018	12/06/2018	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
43	EUCTR2017-002632-17-PT (EUCTR)	16/07/2018	19/04/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mavenclad ® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
44	EUCTR2017-002632-17-AT (EUCTR)	11/07/2018	05/01/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
45	EUCTR2018-000721-31-SE (EUCTR)	04/07/2018	24/04/2018	A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis.	RItuximab Long-Term DOSE Trial in Multiple Sclerosis – RIDOSE-MSA randomized trial of long-term dosage of rituximab in multiple sclerosisThe RIDOSE-MS trial is a multi-centre trial of long-term treatment with rituximab in MS, randomised between two different dosing regimens. Population: Patients with RRMS that has completed the RIFUND-MS trial in either the rituximab or DMF arm. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Intervention: Treatment with rituximab (Mabthera®) 500 mg every six months. Both the previous rituximab and DMF arms from the RIFUND trial will be treated with rituximab in the RIDOSE trial.Control: After one year of treatment in RIDOSE-MS, patients will be randomised 1:1 to either continue with 500 mg every 6 months or 500 mg every 12 months and continue on this treatment schedule for another 3 years.Outcome: Primary outcome will be the proportion of patients remaining with no evidence of disease activity (NEDA) -3 over the randomised period of 3 years. As secondary endpoints progression of disability, brain atrophy, cognitive function and level of serum Neurofilament-Light will be evaluated. In addition, Patient-related outcome scales measuring fatigue, work ability and treatment satisfaction will be analysed. - RIDOSE-MS	Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	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
46	EUCTR2016-004719-10-PT (EUCTR)	02/07/2018	12/02/2018	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
47	EUCTR2017-002632-17-BE (EUCTR)	24/05/2018	01/02/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
48	EUCTR2017-002632-17-NL (EUCTR)	14/05/2018	27/02/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
49	NCT03498131 (ClinicalTrials.gov)	May 9, 2018	6/4/2018	Melatonin in Patients With Multiple Sclerosis (MS).	Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)	Relapsing Remitting Multiple Sclerosis	Drug: 3 mg Melatonin;Drug: 5 mg Melatonin	Providence Health & Services	NULL	Recruiting	18 Years	65 Years	All	30	Early Phase 1	United States
50	EUCTR2012-000541-12-BE (EUCTR)	07/05/2018	09/02/2018	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany
No.	TrialID	Date_ enrollment	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	EUCTR2016-004719-10-GB (EUCTR)	26/04/2018	22/05/2018	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
52	EUCTR2017-002632-17-CZ (EUCTR)	25/04/2018	29/01/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mavenclad ® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
53	EUCTR2018-000620-34-SE (EUCTR)	24/04/2018	14/03/2018	Imatinib treatment for Multiple Sclerosis (MS) Relapses	Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS	Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	INN or Proposed INN: IMATINIB MESILATE Trade Name: Solu-Medrol Product Name: Solu-Medrol INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Department of Clinical Neuroscience, Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	Sweden
54	EUCTR2017-002632-17-SE (EUCTR)	18/04/2018	17/01/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
55	EUCTR2017-002632-17-FR (EUCTR)	10/04/2018	07/02/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mavenclad ® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;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
56	EUCTR2016-004719-10-HR (EUCTR)	27/03/2018	12/04/2018	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
57	EUCTR2017-002632-17-DK (EUCTR)	21/03/2018	01/02/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Sweden
58	EUCTR2017-002632-17-ES (EUCTR)	16/03/2018	25/01/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mavenclad ® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
59	EUCTR2017-001176-31-PT (EUCTR)	12/03/2018	01/03/2018	A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®	BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies	Clinically-isolated syndrome (CIS) and 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B	Bayer AG	,NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Norway;Sweden
60	EUCTR2017-002632-17-FI (EUCTR)	05/03/2018	05/02/2018	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mavenclad ® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;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
61	EUCTR2017-002632-17-HU (EUCTR)	26/02/2018	28/12/2017	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mavenclad ® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Ireland;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
62	EUCTR2017-002632-17-LT (EUCTR)	30/01/2018	21/12/2017	A Quality of Life Study for People with Relapsing Multiple Sclerosis	A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	445	Phase 4	Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
63	EUCTR2016-004719-10-LV (EUCTR)	30/01/2018	10/11/2017	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
64	EUCTR2016-004719-10-BG (EUCTR)	24/01/2018	01/11/2017	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
65	EUCTR2016-004719-10-CZ (EUCTR)	22/01/2018	29/09/2017	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2016-004719-10-HU (EUCTR)	11/01/2018	20/11/2017	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
67	EUCTR2016-004719-10-LT (EUCTR)	29/12/2017	04/12/2017	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
68	EUCTR2017-003328-56-GB (EUCTR)	19/12/2017	31/10/2017	MS-STAT2 - Multiple Sclerosis – Simvastatin Trial 2	A phase 3 randomised, double blind, clinical trial investigating the effectiveness of repurposed simvastatin compared to placebo, in secondary progressive multiple sclerosis, in slowing the progression of disability - MS-STAT2	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: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets INN or Proposed INN: Simvastatin Trade Name: Simvastatine Sandoz 40 mg filmomhulde tabletten Product Name: Simvastatine Sandoz 40 mg filmomhulde tabletten INN or Proposed INN: Simvastatin Trade Name: SimvaHEXAL® 40 mg Filmtabletten Product Name: SimvaHEXAL® 40 mg Filmtabletten INN or Proposed INN: Simvastatin Trade Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG Product Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG INN or Proposed INN: Simvastatin Trade Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película Product Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película INN or Proposed INN: Simvastatin Trade Name: Sivatin 40 mg film-coated tablets Product Name: Sivatin 40 mg film-coated tablets INN or Proposed INN: Simvastatin Trade Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten Product Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten INN or Proposed INN: Simvastatin	University College London Comprehensive Clinical Trials Unit	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1180	Phase 3	United Kingdom
69	EUCTR2017-001176-31-CZ (EUCTR)	07/12/2017	03/08/2017	A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®	BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies	Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B	Bayer AG	,NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
70	EUCTR2017-001176-31-FR (EUCTR)	07/12/2017	16/01/2018	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies	Clinically-isolated syndrome (CIS) and 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Bayer AG	,NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;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
71	EUCTR2016-004719-10-PL (EUCTR)	02/12/2017	24/08/2017	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
72	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
73	NCT03347370 (ClinicalTrials.gov)	November 27, 2017	16/11/2017	A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis	Subcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice Setting	Multiple Sclerosis, Relapsing-Remitting	Drug: SC Peginterferon beta-1a;Drug: SC interferon beta-1a;Drug: SC interferon beta-1b	Biogen	AMS Advanced Medical Services GmbH	Completed	18 Years	N/A	All	626		Germany
74	EUCTR2017-001176-31-GB (EUCTR)	06/11/2017	21/07/2017	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies	Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Bayer AG	,NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
75	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
No.	TrialID	Date_ enrollment	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	EUCTR2017-001176-31-DK (EUCTR)	25/10/2017	14/08/2017	A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®	BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies	Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B	Bayer AG	,NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
77	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
78	EUCTR2016-004719-10-SE (EUCTR)	04/10/2017	28/07/2017	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
79	EUCTR2012-000541-12-FI (EUCTR)	03/10/2017	17/08/2017	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
80	EUCTR2016-004719-10-ES (EUCTR)	02/10/2017	04/07/2017	A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.	Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2012-000541-12-BG (EUCTR)	28/09/2017	04/07/2017	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
82	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
83	EUCTR2017-001176-31-ES (EUCTR)	20/09/2017	12/07/2017	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies	Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden;Portugal;Slovenia
84	EUCTR2017-001176-31-FI (EUCTR)	14/09/2017	10/08/2017	A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®	BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies	Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B	Bayer AG	,NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
85	EUCTR2017-001176-31-AT (EUCTR)	07/09/2017	26/07/2017	A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®	BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies	Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B	Bayer AG	,NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;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
86	EUCTR2012-000541-12-PL (EUCTR)	05/09/2017	27/07/2017	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
87	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
88	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
89	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
90	NCT03232073 (ClinicalTrials.gov)	July 17, 2017	20/7/2017	Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis	Multicenter, Non-comparative Extension to Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis	Multiple Sclerosis	Drug: Ponesimod	Actelion	NULL	Active, not recruiting	18 Years	65 Years	All	800	Phase 3	United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom
No.	TrialID	Date_ enrollment	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	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
92	NCT02903537 (ClinicalTrials.gov)	July 6, 2017	21/7/2016	Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS)	Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS)	Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Chronic Progressive	Drug: Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3);Drug: Interferon-beta	Fundació Institut Germans Trias i Pujol	Clinica Universidad de Navarra, Universidad de Navarra	Unknown status	18 Years	60 Years	All	16	Phase 1	Spain
93	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
94	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
95	EUCTR2012-000541-12-FR (EUCTR)	13/06/2017	17/07/2017	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
No.	TrialID	Date_ enrollment	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	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
97	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
98	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
99	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
100	NCT02907177 (ClinicalTrials.gov)	March 30, 2017	25/8/2016	Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)	Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)	Multiple Sclerosis	Drug: Ponesimod;Other: Placebo	Actelion	NULL	Terminated	18 Years	55 Years	All	136	Phase 3	United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;Russian Federation;Spain;Switzerland;United Kingdom;Croatia;Czech Republic;Finland;Norway
No.	TrialID	Date_ enrollment	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	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
102	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
103	EUCTR2012-000541-12-GR (EUCTR)	21/12/2016	24/08/2016	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
104	EUCTR2012-000541-12-PT (EUCTR)	05/12/2016	19/07/2016	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
105	NCT03561402 (ClinicalTrials.gov)	December 1, 2016	7/6/2018	Biomarkers and Disease Activity in Patients Treated With Teriflunomide (Aubagio)	Association of Possible Biomarkers With Disease Activity in Patients Treated With Teriflunomide (Aubagio)	Multiple Sclerosis, Relapsing-Remitting	Drug: Teriflunomide	McGill University	NULL	Unknown status	18 Years	55 Years	All	75		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
106	EUCTR2012-000541-12-ES (EUCTR)	21/11/2016	11/08/2016	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
107	EUCTR2016-002180-33-PL (EUCTR)	16/11/2016	14/07/2016	Multiple sclerosis therapy with transdermal myelin peptide stimulation.	Multiple sclerosis therapy with transdermal myelin peptide stimulation.	relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: Avonex INN or Proposed INN: Interferon beta 1-A Other descriptive name: INTERFERON BETA -1A	Centrum Neurologii Krzysztof Selmaj	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220	Phase 2	Poland
108	EUCTR2012-000541-12-DE (EUCTR)	15/11/2016	06/07/2016	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
109	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
110	EUCTR2012-000541-12-DK (EUCTR)	07/11/2016	20/07/2016	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
No.	TrialID	Date_ enrollment	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	EUCTR2015-005419-33-LV (EUCTR)	03/11/2016	11/08/2016	Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis	A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing 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: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	1313	Phase 3	Portugal;United States;United Arab Emirates;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany
112	EUCTR2012-000541-12-AT (EUCTR)	02/11/2016	22/07/2016	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
113	EUCTR2015-003471-30-NL (EUCTR)	02/11/2016	26/04/2016	A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify		Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of
114	EUCTR2016-001515-20-IT (EUCTR)	20/10/2016	07/02/2018	nd	EFFECT OF TERIFLUNOMIDE ON T CELL SUBPOPULATIONS INPERIPHERAL BLOOD FROM RRMS PATIENTS - nd	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]	Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) - 28 COMPRESSE Product Name: teriflunomide Product Code: nd	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Italy
115	EUCTR2015-005419-33-FR (EUCTR)	14/10/2016	12/01/2017	Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis	A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing 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: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	1313	Phase 3	Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;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
116	EUCTR2016-003073-18-GB (EUCTR)	29/09/2016	16/09/2016	A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body	A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)	The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Celgene International II Sàrl	NULL	Not Recruiting			Female: no Male: yes	6	Phase 1	United Kingdom
117	EUCTR2015-003471-30-PL (EUCTR)	23/09/2016	15/07/2016	A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify		Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;United States;Czech Republic;Taiwan;Canada;Malaysia;Poland;Romania;Turkey;Netherlands;Italy;Korea, Republic of
118	EUCTR2012-000541-12-HU (EUCTR)	08/09/2016	21/07/2016	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
119	EUCTR2012-000541-12-CZ (EUCTR)	29/08/2016	22/07/2016	Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)	Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT	Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
120	EUCTR2015-000507-44-LT (EUCTR)	11/07/2016	16/05/2016	A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify		Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;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
121	EUCTR2015-000507-44-DE (EUCTR)	29/06/2016	23/02/2016	A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Trade Name: Dysport ® Product Name: Dysport ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport ® Product Name: Dysport ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX	Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
122	EUCTR2015-003471-30-IT (EUCTR)	30/05/2016	07/04/2016	A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Trade Name: DYSPORT ® Product Name: DYSPORT ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT ® Product Name: DYSPORT ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX	Ipsen Innovation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	408	Phase 3	Portugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of
123	EUCTR2015-003471-30-CZ (EUCTR)	27/05/2016	16/03/2016	A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify		Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 3	Portugal;United States;Taiwan;Czech Republic;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of
124	EUCTR2015-004059-29-EE (EUCTR)	16/05/2016	22/02/2016	Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis	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 - CHANGE-MS	Multiple Sclerosis (MS) 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: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available	GeNeuro SA	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 2	Poland;Croatia;Bulgaria;Germany;Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary
125	EUCTR2015-003471-30-PT (EUCTR)	09/05/2016	08/03/2016	A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Trade Name: DYSPORT ® Product Name: DYSPORT ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT ® Product Name: DYSPORT ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX	Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Portugal;Taiwan;Czech Republic;Canada;Poland;Malaysia;Turkey;Romania;Netherlands;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
126	EUCTR2015-000507-44-ES (EUCTR)	04/05/2016	18/03/2016	A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Trade Name: Dysport ® Product Name: Dysport ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport ® Product Name: Dysport ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX	Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 3	Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
127	NCT02749396 (ClinicalTrials.gov)	May 2, 2016	20/4/2016	EPID Multiple Sclerosis Pregnancy Study	Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon ß - a Register-based Study in the Nordic Countries	Multiple Sclerosis	Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG;Drug: Extavia (interferon beta-1b), Novartis Pharma AG;Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd;Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd;Drug: Avonex (interferon beta-1a), Biogen Idec Ltd;Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046);Other: No MSDMDs therapy (control)	Bayer	EPID Research;Biogen;Merck Serono Europe Ltd;Novartis Pharmaceuticals	Completed	N/A	N/A	Female	2089		Finland
128	NCT02649985 (ClinicalTrials.gov)	May 2, 2016	6/1/2016	Microglial Activation Positron Emission Tomography (PET) Brain Imaging in Multiple Sclerosis and Alzheimer's Disease	Microglial Activation Positron Emission Tomography (PET) Brain Imaging in Multiple Sclerosis and Alzheimer's Disease	Multiple Sclerosis;Alzheimer's Disease	Drug: [F-18]PBR06;Drug: [C-11]PBR28	Brigham and Women's Hospital	NULL	Recruiting	18 Years	85 Years	All	105	Phase 1;Phase 2	United States
129	NCT03566251 (ClinicalTrials.gov)	May 1, 2016	11/6/2018	Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis	The Investigation of the Relationship Between Core Stability and Trunk Position Sense With Balance and Functional Mobility in Patients With Multiple Sclerosis	Physical Therapy	Other: Balance;Other: Functional mobility;Other: Core stability;Other: Trunk position sense	Ankara Yildirim Beyazit University	NULL	Completed	18 Years	65 Years	All	74	N/A	Turkey
130	EUCTR2015-000507-44-FR (EUCTR)	29/04/2016	21/03/2016	A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Trade Name: Dysport ® Product Name: Dysport ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport ® Product Name: Dysport ® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX	Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 3	Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;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
131	EUCTR2015-000507-44-BE (EUCTR)	31/03/2016	08/03/2016	A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis	A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify		Ipsen Innovation	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
132	NCT02601131 (ClinicalTrials.gov)	February 2016	28/10/2015	Post-transfusion Platelet Count	Post-transfusion Platelet Count	Leukemia;Multiple Sclerosis	Biological: Platelet transfusion	Region Skane	NULL	Completed	18 Years	N/A	Both	80	N/A	Sweden
133	EUCTR2012-000540-10-PT (EUCTR)	23/10/2015	21/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio ® Product Name: Aubagio ® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Hungary;United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
134	EUCTR2012-000540-10-LT (EUCTR)	21/10/2015	17/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
135	EUCTR2012-000540-10-HU (EUCTR)	15/10/2015	19/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio ® Product Name: Aubagio ® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2012-000540-10-SE (EUCTR)	07/10/2015	14/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio ® Product Name: Aubagio ® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
137	EUCTR2012-000540-10-GR (EUCTR)	02/10/2015	05/11/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
138	NCT02606630 (ClinicalTrials.gov)	October 2015	13/11/2015	[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple Sclerosis	A [C-11]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT-555 on Central Nervous System Inflammation in Subjects With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis	Drug: ABT-555	AbbVie	NULL	Terminated	18 Years	60 Years	All	4	Phase 1	United Kingdom
139	EUCTR2012-000540-10-LV (EUCTR)	25/09/2015	14/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
140	EUCTR2012-000540-10-HR (EUCTR)	23/09/2015	01/10/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2012-000540-10-FI (EUCTR)	23/09/2015	19/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
142	EUCTR2012-000540-10-DE (EUCTR)	23/09/2015	03/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio ® Product Name: Aubagio ® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
143	EUCTR2012-000540-10-ES (EUCTR)	21/09/2015	11/09/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio ® Product Name: Aubagio ® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT -128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Serbia;Portugal;Belarus;United States;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
144	EUCTR2012-000540-10-CZ (EUCTR)	15/09/2015	17/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
145	NCT02486640 (ClinicalTrials.gov)	September 8, 2015	15/6/2015	Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon	BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence	Multiple Sclerosis	Drug: Interferon beta -1b (Betaferon, BAY86-5046);Device: Betaconnect Autoinjector	Bayer	NULL	Completed	18 Years	N/A	All	162		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
146	EUCTR2012-000540-10-PL (EUCTR)	25/08/2015	12/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio ® Product Name: Aubagio ® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
147	NCT03046251 (ClinicalTrials.gov)	August 2015	3/2/2017	Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis	Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis	Multiple Sclerosis	Drug: Natalizumab	State University of New York at Buffalo	NULL	Recruiting	18 Years	N/A	Female	100	Phase 4	United States
148	NCT02542787 (ClinicalTrials.gov)	August 2015	4/9/2015	Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis	A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis	Spasticity in People With Multiple Sclerosis	Drug: VSN16R;Other: Placebo	Canbex Therapeutics Ltd	NULL	Completed	18 Years	70 Years	All	160	Phase 2	United Kingdom
149	NCT02632591 (ClinicalTrials.gov)	August 2015	14/12/2015	Use on Human Beings of Mix of Known Drugs for New Destination - MS Treatment	Use on Human Being of a Mix Between Very Well Known Drugs, Tested Upon Registered Trial n° NCT02606929, to Consider Effectiveness of Improvement After 45 Days	Multiple Sclerosis;Autoimmune Disease;Disseminated or Multiple Sclerosis Nos;Multiple Sclerosis, Acute Relapsing;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic Progressive	Drug: Tetracycline;Drug: statin;Drug: antimycotic;Drug: Fingolimod;Drug: copaxone	Università Popolare Homo & Natura	NULL	Completed	18 Years	65 Years	Both	90	Phase 1	Italy
150	EUCTR2012-000540-10-FR (EUCTR)	31/07/2015	03/08/2015	International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis	Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM	relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
No.	TrialID	Date_ enrollment	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	NCT02425644 (ClinicalTrials.gov)	June 4, 2015	21/4/2015	Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis	Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis	Multiple Sclerosis	Drug: ponesimod;Drug: teriflunomide	Actelion	NULL	Completed	18 Years	55 Years	All	1133	Phase 3	United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic
152	EUCTR2013-002660-17-DK (EUCTR)	02/06/2015	16/04/2015	Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis	Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS	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]	Trade Name: Gilenya Product Name: Fingolmod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	281	Phase 2	Portugal;France;Canada;Finland;Poland;Spain;Denmark;Germany;Italy;United Kingdom;Switzerland
153	EUCTR2015-001197-18-NO (EUCTR)	20/05/2015	15/04/2015	The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events.	The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events.	multiple sclerosis;Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]	Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE	Biogen Idec Norway	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 4	Norway
154	NCT02495766 (ClinicalTrials.gov)	May 11, 2015	3/6/2015	Autologous Mesenchymal Stromal Cells for Multiple Sclerosis	Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis	Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis	Drug: XCEL-MC-ALPHA;Drug: Placebo	Banc de Sang i Teixits	Vall d'Hebron Research Institute (VHIR)	Completed	18 Years	60 Years	All	8	Phase 1;Phase 2	Spain
155	NCT02419378 (ClinicalTrials.gov)	May 2015	31/3/2015	Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential	Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential	Multiple Sclerosis, Relapsing-Remitting	Drug: Alemtuzumab	University Hospital Muenster	Genzyme, a Sanofi Company	Recruiting	18 Years	55 Years	Both	15	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
156	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
157	NCT02638038 (ClinicalTrials.gov)	February 2015	16/12/2015	This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for = 3 Years	A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis	Multiple Sclerosis, Relapsing Remitting	Drug: INT131	InteKrin Therapeutics, Inc.	NULL	Completed	18 Years	50 Years	All	228	Phase 2	NULL
158	EUCTR2014-004412-11-GB (EUCTR)	16/01/2015	19/11/2014	The purpose of this study is to examine the safety and efficacy of VSN16R and the performance in treating spasticity (tightness, stiffness or pull of muscles) in patients with Multiple Sclerosis (MS).	A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects with Multiple Sclerosis	Multiple Sclerosis MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: VSN16R 100mg Product Code: VSN16R INN or Proposed INN: VSN16R Other descriptive name: (R) 3-(5-Dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1- methylethyl) benzamide	Canbex Therapeutics Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 2	United Kingdom
159	NCT02606929 (ClinicalTrials.gov)	January 2015	12/11/2015	Use of Well Known Drugs for New Destination - MS Improvement (MSNT)	Expanded Access Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Multiple Sclerosis Not Responding With Commonly Used Treatments	Multiple Sclerosis;Autoimmune Diseases;Disseminated or Multiple Sclerosis Nos;Multiple Sclerosis, Acute Relapsing;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic Progressive	Drug: Tetracycline - Statin - Antimycotic	Università Popolare Homo & Natura	NULL	Temporarily not available	18 Years	65 Years	Both		Phase 0	Italy
160	EUCTR2014-000709-10-DE (EUCTR)	19/12/2014	13/10/2014	Investigation on how alemtuzumab acts in patients with relapsing remitting multiple sclerosis.	Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential - ALAIN01	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]	Trade Name: LEMTRADA 12 mg Konzentrat zur Herstellung einer Infusionslösung INN or Proposed INN: Alemtuzumab Other descriptive name: ALEMTUZUMAB	Universitätsklinikum Münster	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	15	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
161	EUCTR2014-003209-14-FR (EUCTR)	01/09/2014	18/06/2015	ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS	ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFF	MULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRI 300 mg solution à diluer pour perfusion INN or Proposed INN: NATALIZUMAB	Hôpitaux Universitaires de Strasbourg	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
162	NCT02287948 (ClinicalTrials.gov)	September 2014	6/11/2014	Wii FIT Balance Board to Recording Balance Parameters in Multiple Sclerosis Subjects	Validation Study for Using Wii FIT Balance Board to Recording Balance Parameters in Healthy Subjects and Multiple Sclerosis Subjects	Postural Balance;Multiple Sclerosis	Device: Nintendo Wii Fit Balance Board	University Hospital of Ferrara	NULL	Completed	18 Years	80 Years	Both	40	N/A	Italy
163	NCT02273635 (ClinicalTrials.gov)	September 2014	3/10/2014	Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS	Controlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple Sclerosis	Primary Progressive Multiple Sclerosis;Multiple Sclerosis, Secondary Progressive	Drug: Andrographolides;Drug: placebo	Innobioscience SpA	Pontificia Universidad Catolica de Chile;University of Chile;Universidad Austral de Chile	Recruiting	18 Years	70 Years	Both	68	Phase 1;Phase 2	Chile
164	NCT02159573 (ClinicalTrials.gov)	July 2014	19/5/2014	Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)	A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)	Relapsing-Remitting Multiple Sclerosis	Biological: natalizumab;Drug: dimethyl fumarate	Biogen	NULL	Completed	18 Years	N/A	Both	530	N/A	United States
165	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
No.	TrialID	Date_ enrollment	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	EUCTR2011-005249-12-ES (EUCTR)	03/06/2014	01/04/2014	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 - TERIKIDS	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]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 3	Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China
167	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
168	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
169	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
170	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
171	NCT01892345 (ClinicalTrials.gov)	April 11, 2014	20/6/2013	A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)	Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder	Drug: Eculizumab;Drug: Placebo	Alexion Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	143	Phase 3	United States;Argentina;Australia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Canada;Colombia;Czech Republic;France;Singapore
172	EUCTR2012-000734-19-ES (EUCTR)	10/04/2014	10/01/2014	Bone marrow cell treatment as treatment of multiple sclerosis	Treatment of autologous mesenchymal stem cells derived from bone marrow as a potential therapeutic strategy for the treatment of multiple sclerosis - EMMES	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: XCEL-MC-ALPHA Product Code: XCEL-MC-ALPHA INN or Proposed INN: Autologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved Other descriptive name: Mesenchymal Stem Cells	Banc de Sang i Teixits	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
173	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
174	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
175	NCT02227524 (ClinicalTrials.gov)	April 2014	20/8/2014	Trekking Poles to Aid Multiple Sclerosis Gait Impairment	Trekking Poles to Aid Multiple Sclerosis Gait Impairment	Multiple Sclerosis	Other: No device;Device: Single-point cane (SPC);Device: Four-point cane (FPC);Device: Trekking pole (TP).	Rowan University	NULL	Completed	18 Years	64 Years	All	29	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
176	EUCTR2012-004019-29-DE (EUCTR)	19/09/2013	06/05/2013	Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis	A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis	Relapsing multiple sclerosis 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]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: Secukinumab	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
177	EUCTR2012-005262-35-GB (EUCTR)	14/08/2013	11/06/2013	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11	Clinically isolated syndrome (CIS) and 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	468	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
178	EUCTR2012-005262-35-IT (EUCTR)	14/08/2013	25/06/2013	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11	Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: Recombinant interferon beta-1b	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	468		Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
179	EUCTR2012-004019-29-PT (EUCTR)	02/08/2013	03/06/2013	Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis	A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis	Relapsing 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: Secukinumab Product Code: AIN457	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	380	Phase 2	Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
180	JPRN-UMIN000010094	2013/08/01	01/04/2013	A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica		neuromyelitis optica	4.8mg/kg Sivelestat Sodium will administered constantly for 5 days in combination with 3 days intravenous methyl-prednisolone administration to sero-positive neuromyelitis optica patients who relapsed within 72 hours before starting treatment.	Tohoku University Hospital	NULL	Complete: follow-up complete	20years-old	55years-old	Male and Female	10	Phase 1;Phase 2	Japan
No.	TrialID	Date_ enrollment	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	EUCTR2012-005262-35-AT (EUCTR)	19/07/2013	02/04/2013	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11	Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b	Bayer HealthCare AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	468		Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
182	EUCTR2012-004019-29-CZ (EUCTR)	18/07/2013	13/05/2013	Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis	A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis	Relapsing multiple sclerosis 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]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
183	EUCTR2012-005262-35-SI (EUCTR)	10/07/2013	10/07/2013	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11	Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b	Bayer HealthCare AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	468		Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
184	NCT01896700 (ClinicalTrials.gov)	July 2013	8/7/2013	Methylphenidate to Improve Balance and Walking in MS	Methylphenidate to Improve Balance and Walking in MS	Multiple Sclerosis	Drug: Methylphenidate;Drug: Placebo	Oregon Health and Science University	Portland VA Medical Center	Completed	20 Years	65 Years	All	24	Phase 2;Phase 3	United States
185	EUCTR2012-005262-35-ES (EUCTR)	28/06/2013	13/06/2013	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11	Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	468	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;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
186	EUCTR2012-004019-29-SE (EUCTR)	19/06/2013	12/04/2013	Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis	A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis	Relapsing 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: Secukinumab Product Code: AIN457	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
187	EUCTR2012-004019-29-FI (EUCTR)	19/06/2013	16/05/2013	Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis	A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis	Relapsing 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: Secukinumab Product Code: AIN457	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
188	EUCTR2012-005262-35-FI (EUCTR)	18/06/2013	25/04/2013	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11	Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	468		Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
189	EUCTR2012-005262-35-CZ (EUCTR)	13/06/2013	26/03/2013	A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®	BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11	Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	468	Phase 4	Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
190	NCT01651520 (ClinicalTrials.gov)	June 2013	25/7/2012	Prognosis Value of the Neuronal Damage in Early Multiple Sclerosis	Prognosis Value of the Neuronal Damage Detected by Positrons Emission Tomography (PET) With 11C-Flumazenil in Early Multiple Sclerosis.	Multiple Sclerosis	Drug: PET with 11C-Flumazenil	Assistance Publique - Hôpitaux de Paris	NULL	Active, not recruiting	18 Years	55 Years	All	60	N/A	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
191	EUCTR2012-004019-29-ES (EUCTR)	24/05/2013	24/06/2013	Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis	A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis	Relapsing 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: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB	Novartis Farmacéutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
192	NCT01845584 (ClinicalTrials.gov)	May 2013	26/4/2013	Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.	NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.	Neuromyelitis Optica Spectrum Disorder	Drug: NPB-01	Nihon Pharmaceutical Co., Ltd	NULL	Completed	20 Years	N/A	All	7	Phase 2	Japan
193	EUCTR2012-004019-29-BE (EUCTR)	29/04/2013	23/10/2012	Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis	A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis	Relapsing 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: Secukinumab Product Code: AIN457 Other descriptive name: SECUKINUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden
194	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	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	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
195	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	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	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
No.	TrialID	Date_ enrollment	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	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
197	EUCTR2012-003627-38-CZ (EUCTR)	18/02/2013	12/11/2012	Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis	Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis	Relapsing Remitting 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 Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	114		Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden
198	EUCTR2012-003627-38-BG (EUCTR)	01/02/2013	21/11/2012	Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis	Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis	Relapsing Remitting 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 Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	114	Phase 2	Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden
199	NCT01772199 (ClinicalTrials.gov)	February 2013	17/1/2013	Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis	Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Drug: GSK239512;Drug: Placebo	GlaxoSmithKline	NULL	Completed	18 Years	50 Years	Both	131	Phase 2	Bulgaria;Canada;Czech Republic;Germany;Spain;Sweden;Ukraine;United Kingdom
200	EUCTR2012-003627-38-SE (EUCTR)	30/01/2013	10/09/2012	Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis	Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis	Relapsing Remitting Multiple Sclerosis MedDRA version: 16.0;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 Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	114		Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;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
201	EUCTR2012-003627-38-DE (EUCTR)	24/01/2013	27/09/2012	Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis	Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis	Relapsing Remitting Multiple Sclerosis MedDRA version: 15.0;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 Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	114		Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden
202	EUCTR2012-003627-38-GB (EUCTR)	15/01/2013	21/11/2012	Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis	Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis	Relapsing Remitting 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]		GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	114	Phase 2	Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden
203	EUCTR2012-003627-38-ES (EUCTR)	17/12/2012	02/10/2012	Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis	Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis.	Relapsing Remitting 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 Code: GSK2395612 INN or Proposed INN: GSK239512 Product Code: GSK239512 INN or Proposed INN: GSK239512 Product Code: GSK239512 INN or Proposed INN: GSK239512 Product Code: GSK239512 INN or Proposed INN: GSK239512	GlaxoSmithKline, S.A.	NULL	Not Recruiting			Female: yes Male: yes	114		Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden
204	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	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: 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
205	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	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	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
206	EUCTR2012-003056-36-IT (EUCTR)	21/11/2012	15/10/2012	Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis	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	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 MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate	NOVARTIS FARMA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1530		Portugal;United States;Estonia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Australia;Bulgaria;Latvia;Germany;Sweden
207	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	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: 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
208	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	18	N/A	United States
209	EUCTR2012-003056-36-HU (EUCTR)	31/10/2012	03/09/2012	Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis	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	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	Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden
210	EUCTR2012-000957-30-CZ (EUCTR)	11/09/2012	18/06/2012	BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis	BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis	Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 17.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: BOTOX ® Product Name: BOTOX ® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A	Allergan Ltd.	NULL	Not Recruiting			Female: yes Male: yes	184		Portugal;France;United States;Czech Republic;Canada;Poland;Belgium;Russian Federation;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
211	NCT01706055 (ClinicalTrials.gov)	September 2012	7/9/2012	Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)	Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®	Multiple Sclerosis	Biological: Interferon beta -1b (Betaseron, BAY86-5046)	Bayer	NULL	Completed	18 Years	N/A	All	629	N/A	Poland
212	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	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 I	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
213	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.	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
214	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	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: 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
215	EUCTR2010-020328-23-PT (EUCTR)	06/01/2012	17/11/2011	Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.	A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	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]	Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono SA - Geneva, an affiliate of Merck KGaA	,NULL	Not Recruiting			Female: yes Male: yes	358	Phase 2	Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	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
217	EUCTR2010-020328-23-AT (EUCTR)	23/11/2011	28/10/2011	Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.	A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	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: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono SA - Geneva, an affiliate of Merck KGaA	,NULL	Not Recruiting			Female: yes Male: yes	358	Phase 2	Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
218	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	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 I	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;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Bulgaria;Germany;New Zealand
219	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	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 I	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/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;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;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
220	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	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 I	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/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
No.	TrialID	Date_ enrollment	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	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
222	NCT01403376 (ClinicalTrials.gov)	September 2011	14/7/2011	Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide	Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference	Multiple Sclerosis	Drug: teriflunomide;Drug: Interferon-ß-1;Biological: Influenza vaccine	Sanofi	NULL	Completed	18 Years	59 Years	All	128	Phase 2	Austria;Canada;Germany;Russian Federation;Ukraine
223	EUCTR2010-020328-23-LV (EUCTR)	19/07/2011	16/05/2011	Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.	A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	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]	Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Latvia;Norway;Germany;Netherlands
224	EUCTR2011-001160-21-DE (EUCTR)	18/07/2011	20/05/2011	Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide	Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVA	Multiple sclerosis MedDRA version: 14.0;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: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Trade Name: Mutagrip Product Name: Mutagrip	sanofi-aventis recherche & developpement	NULL	Not Recruiting			Female: yes Male: yes	120		Canada;Ukraine;Austria;Russian Federation;Germany
225	EUCTR2011-001160-21-AT (EUCTR)	06/07/2011	31/05/2011	Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide	Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVA	Multiple sclerosis MedDRA version: 14.0;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: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Trade Name: Mutagrip Product Name: Mutagrip	sanofi-aventis recherche & developpement	NULL	Not Recruiting			Female: yes Male: yes	120		Germany;Russian Federation;Ukraine;Canada;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
226	NCT01451723 (ClinicalTrials.gov)	July 2011	11/10/2011	Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II	Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS	Multiple Sclerosis	Drug: Polyphenon E;Other: Placebo	Louisiana State University Health Sciences Center in New Orleans	National Center for Complementary and Integrative Health (NCCIH)	Terminated	18 Years	60 Years	All	11	Phase 2	United States
227	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	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 I	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/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
228	EUCTR2010-020338-25-PL (EUCTR)	04/06/2011	14/05/2011	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: 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
229	EUCTR2010-020338-25-BE (EUCTR)	26/05/2011	22/09/2010	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]	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	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
230	EUCTR2011-001956-12-CZ (EUCTR)	25/05/2011	04/05/2011	Biological Efficacy of Interferon ß Therapy in Patients with Multiple Sclerosis	Monitoring of MxA mRNA Expression as a Marker of Rresponse to Interferon ß Therapy in Patients with Multiple Sclerosis.	To correlate bioactivity of IFNß reflected by level of MxA expression and clinical course of MS To measure expression of MxA protein in patients treated with IFNß depending on NAbs statusNAbs positive cohorts will be correlated NAbs titer with level of MxA expression, respectively if the MxA decrease is not preceding NAbs positivity. The MxA induction test will be tested.	Trade Name: Avonex ® Product Name: Avonex ® Product Code: EU/1/97/033/002 Trade Name: Betaferon ® Product Name: Betaferon ® Product Code: EU/1/95/003/005-010 Trade Name: Rebif 22® Product Name: Rebif 22® Product Code: EU/1/98/063/001-003 Trade Name: Rebif 44® Product Name: Rebif 44® Product Code: EU/1/98/063/004-006 Trade Name: Extavia ® Product Name: Extavia ® Product Code: EU/1/08/454/001-002, EU/1/08/454/005-007	University Hospital Motol	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	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
231	EUCTR2009-017978-21-IT (EUCTR)	16/05/2011	05/01/2012	Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials	Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE). - PREMIERE	Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders 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: Cladribine Tablet INN or Proposed INN: CLADRIBINE Other descriptive name: 2-CdA , 2-chloro-2'-deoxy-ß-D-adenosine	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes	2175	Phase 3	Portugal;United Arab Emirates;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;India;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United States Minor Outlying Islands;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Georgia;Germany;Sweden
232	EUCTR2010-020338-25-BG (EUCTR)	11/05/2011	19/01/2011	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: 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	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
233	EUCTR2010-020328-23-LT (EUCTR)	09/05/2011	02/03/2011	Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.	A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	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: Vigantol Oil Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
234	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
235	EUCTR2010-020328-23-EE (EUCTR)	26/04/2011	21/03/2011	Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment.	A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	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: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
236	EUCTR2010-020328-23-BE (EUCTR)	01/04/2011	18/11/2010	A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono SA-Geneva an affiliate of Merck KgaA, Darmstadt	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 2	Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy
237	EUCTR2010-023172-12-PT (EUCTR)	30/03/2011	01/02/2011	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	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	Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	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
238	EUCTR2010-023172-12-DK (EUCTR)	23/03/2011	26/04/2011	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	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	Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	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;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
239	EUCTR2010-023172-12-GR (EUCTR)	15/03/2011	27/01/2011	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	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	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 Other descriptive name: NA Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide	sanofi-aventis group	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
240	EUCTR2010-023172-12-GB (EUCTR)	14/03/2011	20/12/2010	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	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	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
No.	TrialID	Date_ enrollment	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	EUCTR2010-020328-23-IT (EUCTR)	10/03/2011	07/02/2011	A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR	A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR	RELAPSING REMITTING MULTIPLE SCLEROSIS MedDRA version: 9.1;Level: PT;Classification code 10063399	Trade Name: VIGANTOL OIL INN or Proposed INN: Colecalciferol	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 2	Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy
242	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	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 I	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/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
243	EUCTR2010-020338-25-DK (EUCTR)	02/03/2011	07/02/2011	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	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: 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
244	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	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 I	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	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;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
245	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	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 I	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/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
No.	TrialID	Date_ enrollment	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	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	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
247	EUCTR2010-020515-37-DK (EUCTR)	14/02/2011	03/01/2011		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: 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
248	EUCTR2010-023172-12-BE (EUCTR)	08/02/2011	29/11/2010	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	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	Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	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	Phase 3	Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
249	NCT02073474 (ClinicalTrials.gov)	February 2011	21/2/2014	An Observational Post-Marketing Safety Registry of Sativex®	An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex®	Multiple Sclerosis;Diabetes;Cancer;Neuropathic Pain	Drug: Sativex ®	GW Pharmaceuticals Ltd.	NULL	Completed	N/A	N/A	All	978	N/A	NULL
250	EUCTR2010-020328-23-DE (EUCTR)	31/01/2011	27/10/2010	Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment.	A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	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: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Portugal;Estonia;Finland;Lithuania;Austria;Italy;Switzerland;Belgium;Denmark;Germany;Latvia;Netherlands;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
251	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.	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
252	EUCTR2010-023172-12-SK (EUCTR)	26/01/2011	20/12/2010	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	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	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	Phase 3	Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
253	EUCTR2010-020338-25-GR (EUCTR)	21/01/2011	17/01/2011	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]	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	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
254	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	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 I	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/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
255	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	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 I	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/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
No.	TrialID	Date_ enrollment	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	EUCTR2010-023172-12-IT (EUCTR)	13/01/2011	08/02/2011	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 - ND	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 - ND	Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245	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;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
257	EUCTR2010-020328-23-NL (EUCTR)	06/01/2011	16/09/2010	A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono The Netherlands - a division of Merck B.V.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 2	Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy
258	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
259	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	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: 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	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
260	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	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 I	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	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;Poland;Brazil;Belgium;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
261	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	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
262	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	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
263	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
264	EUCTR2010-020338-25-FI (EUCTR)	15/12/2010	15/12/2010	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]	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	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
265	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]	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	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
No.	TrialID	Date_ enrollment	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	EUCTR2010-020328-23-DK (EUCTR)	09/12/2010	08/11/2010	Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.	A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	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: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
267	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	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
268	EUCTR2009-011470-15-NL (EUCTR)	03/12/2010	03/06/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 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]		ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden
269	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	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 I	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/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;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;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
270	EUCTR2010-020515-37-FR (EUCTR)	19/11/2010	06/09/2010	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.	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: 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
271	EUCTR2009-015556-15-AT (EUCTR)	19/11/2010	07/06/2010	A Multicenter, Randomized, Rater-Blind, 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	A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
272	EUCTR2010-020338-25-HU (EUCTR)	17/11/2010	29/09/2010	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: 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	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
273	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	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 I	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]	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	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
274	EUCTR2010-020515-37-IT (EUCTR)	25/10/2010	14/09/2010		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 - ND	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
275	EUCTR2010-020328-23-FI (EUCTR)	21/10/2010	27/08/2010	Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.	A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR	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: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol , Vitamin D3	Merck Serono	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
276	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	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: 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
277	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	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
278	EUCTR2010-020515-37-SK (EUCTR)	18/10/2010	03/08/2010	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.	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	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
279	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.	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
280	EUCTR2010-020515-37-GR (EUCTR)	05/10/2010	04/10/2010	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.	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	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
No.	TrialID	Date_ enrollment	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	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	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: 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	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
282	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	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: 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
283	EUCTR2009-010788-18-ES (EUCTR)	27/09/2010	08/01/2010	Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab.	Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab.	Esclerosis Multiple de Recaida-Remision/Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MABCAMPATH 10 mg/ml concentrado para solución para perfusión INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
284	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.	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.	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
285	EUCTR2009-011470-15-PL (EUCTR)	14/09/2010	25/05/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800	ACTELION Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
No.	TrialID	Date_ enrollment	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	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	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: 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
287	EUCTR2009-015556-15-GB (EUCTR)	02/09/2010	17/03/2010	A Multicenter, Randomized, Rater-Blind, 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	A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
288	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.	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
289	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		18		BOTH	100	Phase 3	NULL
290	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
No.	TrialID	Date_ enrollment	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	EUCTR2009-015556-15-DK (EUCTR)	25/08/2010	17/06/2010	A Multicenter, Randomized, Rater-Blind, 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	A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
292	EUCTR2009-011470-15-DE (EUCTR)	20/08/2010	08/04/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN:	ACTELION Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
293	EUCTR2009-015556-15-DE (EUCTR)	20/08/2010	19/03/2010	A Multicenter, Randomized, Rater-Blind, 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	A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
294	EUCTR2009-015556-15-NL (EUCTR)	13/08/2010	08/04/2010	A Multicenter, Randomized, Rater-Blind, 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	A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
295	EUCTR2009-011470-15-BG (EUCTR)	12/08/2010	30/04/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD	ACTELION Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;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
296	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	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: 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
297	EUCTR2009-011470-15-AT (EUCTR)	03/08/2010	28/06/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN:	ACTELION Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
298	NCT00997438 (ClinicalTrials.gov)	August 2010	16/10/2009	Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis	Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis	Multiple Sclerosis	Dietary Supplement: Lipoic Acid	Portland VA Medical Center	Oregon Health and Science University	Completed	18 Years	N/A	All	69	Phase 1	United States
299	EUCTR2009-015556-15-GR (EUCTR)	13/07/2010	14/12/2010	A Multicenter, Randomized, Rater-Blind, 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	A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
300	EUCTR2009-011470-15-HU (EUCTR)	08/07/2010	01/06/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800	ACTELION Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2009-015556-15-PT (EUCTR)	02/07/2010	30/03/2010	A Multicenter, Randomized, Rater-Blind, 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	A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
302	NCT01171209 (ClinicalTrials.gov)	July 2010	8/7/2010	REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients	REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients	Multiple Sclerosis	Drug: Interferon-beta and human leukocyte Interferon-a	Melinda Magyari	University of Copenhagen	Completed	18 Years	55 Years	Both	10	Phase 2	Denmark
303	EUCTR2009-011470-15-GB (EUCTR)	22/06/2010	29/03/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD	ACTELION Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	Sweden;United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands
304	EUCTR2009-015556-15-IT (EUCTR)	07/06/2010	07/06/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399	Trade Name: TYSABRI INN or Proposed INN: Natalizumab Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate Trade Name: REBIF INN or Proposed INN: Interferon beta -1a Trade Name: REBIF *SC 12SIR 6000000UI 22MCG INN or Proposed INN: Interferon beta -1a	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
305	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]	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	76		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;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
306	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.	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
307	EUCTR2009-015556-15-ES (EUCTR)	24/05/2010	24/03/2010	Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: TYSABRI 300 mg concentrado para solución para perfusión INN or Proposed INN: NATALIZUMAB Other descriptive name: NATALIZUMAB Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada INN or Proposed INN: GLATIRAMERO ACETATO Other descriptive name: GLATIRAMER ACETATE Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
308	NCT01093326 (ClinicalTrials.gov)	May 12, 2010	24/3/2010	Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis	Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis	Multiple Sclerosis	Drug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mg	Actelion	NULL	Active, not recruiting	18 Years	55 Years	All	353	Phase 2	United States;Austria;Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Czech Republic
309	EUCTR2009-015556-15-FI (EUCTR)	07/05/2010	24/02/2010	A Multicenter, Randomized, Rater-Blind, 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	A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
310	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.	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
No.	TrialID	Date_ enrollment	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	NCT01354665 (ClinicalTrials.gov)	May 2010	16/5/2011	Depression and Fatigue in MS Patients Treated With Betaferon.	The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis.	Multiple Sclerosis	Biological: Interferon beta -1b (Betaferon, BAY86-5046)	Bayer	NULL	Completed	18 Years	N/A	Both	567	N/A	Poland
312	EUCTR2009-011470-15-CZ (EUCTR)	30/04/2010	29/03/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD	ACTELION Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden
313	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	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
314	EUCTR2009-011470-15-SE (EUCTR)	12/04/2010	04/03/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
315	EUCTR2009-016824-29-DK (EUCTR)	06/04/2010	25/02/2010	REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIR	REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIR	Multiple Sclerosis MedDRA version: 12.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Multiferon INN or Proposed INN: HUMAN LEUCOCYTE INTERFERON-ALPHA Other descriptive name: HUMAN LEUCOCYTE INTERFERON-ALPHA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA -1B Other descriptive name: INTERFERON BETA -1B	Dansk Multipel Sclerose Center	NULL	Not Recruiting			Female: yes Male: yes	10		Denmark
No.	TrialID	Date_ enrollment	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	EUCTR2009-011470-15-FI (EUCTR)	30/03/2010	09/02/2010	An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.	Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD	ACTELION Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	353	Phase 2	United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
317	EUCTR2009-011088-35-DE (EUCTR)	24/03/2010	05/02/2010	Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS	Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS	Patients with Multiple Sclerosis (MS) or Clinically isolated syndrome suggestive for MS (CIS) are investigated. The main objective is to conserve data about changes in the VIP/PACAP (vasoactive intestinal polypaptide/pituitary adenylate cyclase activating polypeptide) system in stresses patients who start a immunomodulatory treatment with glatiramer acetate (Copaxone).	Trade Name: Copaxone Product Name: copaxone Product Code: 52069.00.01 INN or Proposed INN: glatiramer acetate	Philipps-Universität Marburg	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Germany
318	EUCTR2008-003706-33-GR (EUCTR)	10/03/2010	12/03/2009	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	642	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
319	EUCTR2009-012431-15-CZ (EUCTR)	21/01/2010	02/12/2009	Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®.	Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®.	Studie se zabývá lécbou hyperaktivního neurogeního detruzoru u pacientu, kterí trpí príznaky hyperaktivního mocového mechýre jako dusledek spinálního poranení nebo roztroušené sklerózy. K lécbe se pužívá botulinumotoxin. Ve studii se porovnávaní dve ruzné formy aplikace studjiního léku.	Trade Name: Botox Other descriptive name: BOTULINUM TOXIN TYPE A	Krajská nemocnice Liberec, a.s.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40		Czech Republic
320	EUCTR2008-004954-34-AT (EUCTR)	21/01/2010	09/12/2008	Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)	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: 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: Rebif INN or Proposed INN: Interferon-beta 1a	Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	492		Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;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
321	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.	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
322	NCT01101776 (ClinicalTrials.gov)	January 2010	8/4/2010	Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.	Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting	Multiple Sclerosis	Drug: Interferon beta -1a (Rebif)	Merck KGaA	Merck Serono Australia Pty Ltd	Completed	18 Years	N/A	Both	49	N/A	Australia
323	EUCTR2008-008554-23-SE (EUCTR)	29/12/2009	26/06/2009	Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF	Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF	IFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation). MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Trade Name: Rebif Product Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	The Multiple Sclerosis Research Group, Department of Clinical Neuroscience	NULL	Not Recruiting			Female: yes Male: yes	100		Sweden
324	NCT01051817 (ClinicalTrials.gov)	December 2009	19/1/2010	POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler	A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis	Relapsing-remitting Multiple Sclerosis;RRMS	Drug: AIN457;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	55 Years	All	73	Phase 2	Czech Republic;Russian Federation;Ukraine;Serbia;Sweden
325	EUCTR2009-013884-21-DE (EUCTR)	18/11/2009	09/09/2009	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 14.0;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: PEG -liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Enceladus Pharmaceuticals BV	NULL	Not Recruiting			Female: yes Male: yes	90		Poland;Belgium;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
326	EUCTR2009-013884-21-BE (EUCTR)	13/11/2009	10/09/2009	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Product Name: PEG -liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Poland;Belgium;Germany
327	EUCTR2006-003361-14-CZ (EUCTR)	12/10/2009	05/05/2009	Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	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] - Immune System Diseases [C20]	Product Name: teriflunomide Product Code: HMR1726D 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	1080		Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden
328	NCT02275741 (ClinicalTrials.gov)	October 2009	22/10/2014	Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis	Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Biological: prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal)	Dr. med. Micha Loebermann	NULL	Completed	18 Years	70 Years	All	226		Germany
329	EUCTR2006-003361-14-EE (EUCTR)	25/09/2009	19/08/2009	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Product Name: teriflunomide Product Code: HMR1726D 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	1080		Portugal;Czech Republic;Estonia;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
330	EUCTR2008-002626-11-SE (EUCTR)	02/07/2009	24/04/2009	Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis	Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSIT	Severe progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Trade Name: Mabthera Other descriptive name: RITUXIMAB	Dept of Neurology	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
331	EUCTR2008-003706-33-FR (EUCTR)	02/07/2009	12/03/2009	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono International	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	642	Phase 3	Portugal;Germany;Bulgaria;France;Norway;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
332	EUCTR2008-004954-34-BG (EUCTR)	28/05/2009	29/05/2009	Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)	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: 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: Rebif INN or Proposed INN: Interferon-beta 1a	Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	492		Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
333	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	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
334	NCT01075880 (ClinicalTrials.gov)	May 2009	24/2/2010	Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®	Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif	Multiple Sclerosis, Relapsing-Remitting	Drug: Rebif (Interferon beta-1a)	Merck KGaA	Merck spol.s.r.o., Czech Republic	Completed	18 Years	65 Years	Both	300	N/A	Czech Republic
335	EUCTR2008-004954-34-IT (EUCTR)	08/04/2009	12/03/2009	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	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 at high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Trade Name: REBIF *SC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta -1a	MERCK SERONO SA	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
336	EUCTR2008-003706-33-AT (EUCTR)	02/04/2009	24/11/2008	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
337	EUCTR2008-003706-33-NO (EUCTR)	18/03/2009	09/12/2008	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
338	EUCTR2008-004954-34-LV (EUCTR)	12/03/2009	27/02/2009	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	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 S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	492		Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Germany
339	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	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
340	EUCTR2008-003706-33-PT (EUCTR)	06/03/2009	17/12/2008	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;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
341	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	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
342	EUCTR2008-003706-33-IT (EUCTR)	02/03/2009	23/02/2009	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORACLE Cladribine in Early MS (ORACLE MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORACLE Cladribine in Early MS (ORACLE MS)	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Product Name: CLADRIBINE INN or Proposed INN: Cladribine Trade Name: REBIF *SC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta -1a	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes	642	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
343	EUCTR2008-004954-34-EE (EUCTR)	13/02/2009	08/01/2009	Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)	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: 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: Rebif INN or Proposed INN: Interferon-beta 1a	Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	492		Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
344	EUCTR2008-004954-34-PT (EUCTR)	06/02/2009	05/01/2009	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	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 S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
345	NCT00836719 (ClinicalTrials.gov)	February 2009	3/2/2009	Safety of Polyphenon E in Multiple Sclerosis Pilot Study	Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis	Multiple Sclerosis	Drug: Polyphenon E	Louisiana State University Health Sciences Center in New Orleans	National Center for Complementary and Integrative Health (NCCIH)	Completed	18 Years	65 Years	All	10	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
346	EUCTR2008-003706-33-ES (EUCTR)	29/01/2009	09/12/2008	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS).Sujetos con un primer episodio de desmielinización clínica (Síndrome aislado desde el punto de vista clínico (CIS)) de alto riesgo de conversión a Esclerosis Múltiple (EM). MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2?-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	642	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
347	EUCTR2007-001377-28-PT (EUCTR)	09/01/2009	25/08/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;Austria
348	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	16	Phase 1	Australia;Sweden
349	NCT01080027 (ClinicalTrials.gov)	October 2008	2/3/2010	Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)	An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life Settings	Multiple Sclerosis, Relapsing Remitting	Drug: Rebif ® New Formulation	Merck KGaA	Merck A.E., Greece;Merck OY, Finland;Merck B.V., Netherlands;Merck A.B., Sweden;Merck, S.A., Portugal	Completed	18 Years	60 Years	Both	254	N/A	Greece
350	EUCTR2007-001377-28-DE (EUCTR)	01/09/2008	15/05/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;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
351	NCT01184833 (ClinicalTrials.gov)	September 2008	18/8/2010	Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis	Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis	Drug: Interferon beta -1b (Betaseron, BAY86-5046)	Bayer	NULL	Completed	18 Years	N/A	Both	852	N/A	Poland
352	EUCTR2007-000381-20-NL (EUCTR)	29/08/2008	01/02/2008		A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). -	Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3b	Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
353	EUCTR2006-003361-14-DK (EUCTR)	29/08/2008	22/07/2008	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Product Name: teriflunomide Product Code: HMR1726D 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	1080		Portugal;Estonia;Czech Republic;Finland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
354	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	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
355	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	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
356	EUCTR2007-001377-28-NL (EUCTR)	15/07/2008	29/05/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;Austria
357	EUCTR2007-001377-28-AT (EUCTR)	26/06/2008	27/05/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;Austria
358	EUCTR2007-001377-28-FR (EUCTR)	11/06/2008	29/02/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;Austria
359	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	40	Phase 2	United States
360	EUCTR2007-000381-20-IT (EUCTR)	29/05/2008	20/03/2008	na	VEDI ITALIANO - CLARITY EXTENTION	SCLEROSI MULTIPLA A RICADUTE E REMISSIONI 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: CLADRIBINA Product Code: NA INN or Proposed INN: Cladribine	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes	1100		Portugal;Estonia;Greece;Finland;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;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
361	EUCTR2007-007394-22-GB (EUCTR)	22/05/2008	11/04/2008	The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning	The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning	Multiple Sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive	Trade Name: Tysabri Product Name: Tysabri	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 4	United Kingdom
362	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	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
363	EUCTR2007-000381-20-PT (EUCTR)	28/04/2008	15/01/2008		A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). -	Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3b	Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
364	NCT01414816 (ClinicalTrials.gov)	April 2008	13/7/2011	Betaferon® Regulatory Post-Marketing Surveillance	Betaferon® Regulatory Post-Marketing Surveillance	Multiple Sclerosis;Clinically Isolated System	Drug: Interferon beta -1b (Betaseron, BAY86-5046)	Bayer	NULL	Completed	12 Years	N/A	Both	355	N/A	Korea, Republic of
365	EUCTR2007-000192-42-IT (EUCTR)	10/03/2008	31/07/2007	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND	urinary incontinence caused by neurogenic detrusor overactivity (spinal lesion or multiple sclerosis) MedDRA version: 9.1;Level: LLT;Classification code 10029279;Term: Neurogenic bladder	Trade Name: BOTOX INN or Proposed INN: Botulinum toxin	ALLERGAN	NULL	Not Recruiting			Female: yes Male: yes	260		Portugal;United Kingdom;Germany;Netherlands;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
366	EUCTR2006-003361-14-PT (EUCTR)	07/03/2008	07/01/2008	Multiple Sclerosis study to document the safety of two doses of teriflunomide	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Multiple sclerosis MedDRA version: 18.1;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: HMR1726D 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	1080	Phase 3	Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
367	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	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
368	NCT00984984 (ClinicalTrials.gov)	March 2008	24/9/2009	Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses	Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses	Multiple Sclerosis, Relapsing-Remitting	Drug: methylprednisolone PO;Drug: methylprednisolone IV	Rennes University Hospital	NULL	Recruiting	18 Years	55 Years	Both	200	Phase 3	France
369	EUCTR2006-003361-14-NL (EUCTR)	12/02/2008	07/01/2008	Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	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] - Immune System Diseases [C20]	Product Name: teriflunomide Product Code: HMR1726D 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	1080		Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Norway;Sweden
370	EUCTR2004-000555-42-GB (EUCTR)	05/02/2008	03/03/2005	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	Multiple sclerosis		Sanofi-aventis US, Inc	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3	Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;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
371	EUCTR2007-003226-19-PT (EUCTR)	01/02/2008	24/10/2007	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	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	1000		Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
372	EUCTR2007-005414-40-IT (EUCTR)	21/12/2007	28/11/2007	Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND	Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND	Patients with an established and stable Multiple Sclerosis (according to Poser criteria). MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Trade Name: KEPPRA INN or Proposed INN: Levetiracetam	AZIENDA SANITARIA N. 3 GENOVESE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
373	EUCTR2007-000381-20-FR (EUCTR)	14/12/2007	17/10/2007		A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS	Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)	Merck Serono International S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3b	Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
374	EUCTR2006-002982-38-LT (EUCTR)	30/11/2007	01/10/2006	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)	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: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
375	EUCTR2007-003226-19-DE (EUCTR)	23/10/2007	15/07/2008	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	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	1000		Portugal;Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;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
376	NCT01235455 (ClinicalTrials.gov)	August 2007	4/11/2010	Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors	Portuguese BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis (MS) After Conversion to Betaferon by Using Elements of the BetaPlus Program	Relapsing Remitting Multiple Sclerosis (RRMS);Secondary Progressive Multiple Sclerosis (SPMS)	Drug: Interferon beta -1b (Betaseron, BAY86-5046)	Bayer	NULL	Completed	18 Years	N/A	Both	10	N/A	Portugal
377	EUCTR2006-003361-14-SE (EUCTR)	24/07/2007	27/06/2007	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Product Name: teriflunomide Product Code: HMR1726D 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	1080	Phase 3	Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
378	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	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
379	EUCTR2004-000555-42-EE (EUCTR)	06/07/2007	18/04/2007	A randomized, double-blind, placebo-controlled, parallel group design study toevaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing thefrequency of relapses and delaying the accumulation of physical disability insubjects with multiple sclerosis with relapses.	A randomized, double-blind, placebo-controlled, parallel group design study toevaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing thefrequency of relapses and delaying the accumulation of physical disability insubjects with multiple sclerosis with relapses.	Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term:	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	Not Recruiting			Female: yes Male: yes	1080		Portugal;Czech Republic;United Kingdom;Denmark;Norway;Estonia;Italy;Sweden
380	EUCTR2006-002982-38-PT (EUCTR)	29/05/2007	22/02/2007	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)	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 S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;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
381	EUCTR2006-003361-14-IT (EUCTR)	23/05/2007	07/03/2007	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND	Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse	Product Name: teriflunomide Product Code: HMR1726D Product Name: teriflunomide Product Code: HMR1726D	sanofi-aventis recherche de veloppement	NULL	Not Recruiting			Female: yes Male: yes	1080		Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
382	EUCTR2006-005460-30-IT (EUCTR)	22/05/2007	27/10/2008	POPART?MUS Prevention of Post Partum Relapses with Progestin and Estradiolin Multiple sclerosis - POPART`MUS	POPART?MUS Prevention of Post Partum Relapses with Progestin and Estradiolin Multiple sclerosis - POPART`MUS	Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Trade Name: DEMESTRIL SEPTEM INN or Proposed INN: Estradiol Trade Name: LUTENYL INN or Proposed INN: Nomegestrol	OSPEDALI CIVILI DI LIONE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no	300		Italy
383	EUCTR2004-000555-42-CZ (EUCTR)	14/05/2007	09/03/2007	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide	sanofi-aventis U.S Inc	NULL	Not Recruiting			Female: yes Male: yes	1080		Portugal;United Kingdom;Czech Republic;Denmark;Estonia;Norway;Italy;Sweden
384	EUCTR2006-002982-38-GR (EUCTR)	08/05/2007	29/12/2006	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)	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: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
385	EUCTR2006-000704-17-BE (EUCTR)	25/04/2007	06/07/2006	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302	Relapsing-remitting multiple sclerosis (RRMS)	Product Code: FTY720 INN or Proposed INN: Fingolimod	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	1275		Portugal;Hungary;Greece;Spain;Belgium;Austria;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
386	EUCTR2006-000704-17-HU (EUCTR)	16/04/2007	27/07/2006	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302	Relapsing-remitting multiple sclerosis (RRMS)	Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	1275		Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
387	EUCTR2006-002982-38-DE (EUCTR)	16/03/2007	10/10/2006	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)	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 S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
388	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)	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
389	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)	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
390	EUCTR2006-003361-14-GB (EUCTR)	23/01/2007	29/09/2006	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	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]		sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3	Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;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
391	EUCTR2006-002982-38-SK (EUCTR)	12/01/2007	06/10/2006	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)	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;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
392	EUCTR2006-002982-38-FR (EUCTR)	05/01/2007	24/10/2006	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)	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: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a	Serono International SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
393	EUCTR2006-002982-38-DK (EUCTR)	20/12/2006	30/11/2006	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)	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: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Denmark;Belgium;Estonia;Spain;Greece
394	EUCTR2006-002982-38-FI (EUCTR)	19/12/2006	19/10/2006	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)	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 S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
395	EUCTR2006-000704-17-GR (EUCTR)	19/12/2006	11/08/2006	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302	Relapsing-remitting multiple sclerosis (RRMS)	Product Code: FTY720 INN or Proposed INN: Fingolimod Product Name: Interferon beta -1a INN or Proposed INN: interferon beta -1a	Novartis Pharma Services AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1275		Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;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
396	EUCTR2006-003361-14-FI (EUCTR)	19/12/2006	10/11/2006	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses	Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Product Name: teriflunomide Product Code: HMR1726D 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	1080	Phase 3	Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
397	EUCTR2006-002982-38-ES (EUCTR)	13/12/2006	10/03/2010	Ensayo clínico multicéntrico en Fase III, randomizado, doble-ciego, controlado con placebo, de Rebif New Formulation (44 mcg tres veces por semana y 44 mcg una vez por semana) en pacientes con alto riesgo de conversión a esclerosis múltiple.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)	Ensayo clínico multicéntrico en Fase III, randomizado, doble-ciego, controlado con placebo, de Rebif New Formulation (44 mcg tres veces por semana y 44 mcg una vez por semana) en pacientes con alto riesgo de conversión a esclerosis múltiple.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 44 microgramos solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A	Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
398	EUCTR2006-002982-38-AT (EUCTR)	04/12/2006	29/09/2006	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)	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: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
399	EUCTR2006-002982-38-BE (EUCTR)	29/11/2006	14/09/2006	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)	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 S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, Germany	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
400	EUCTR2006-000606-23-ES (EUCTR)	23/11/2006	15/03/2012	?Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase	Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif	Not applicalbe 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: Rebif 22 y 44 mcg Product Name: Interferon-beta -1a Other descriptive name: INTERFERON BETA -1A	Merck, S.L.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase -	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
401	EUCTR2006-002982-38-IT (EUCTR)	09/11/2006	04/12/2006	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 - REFLEX	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 - REFLEX	clinically isolated syndrome suggestive of multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Interferon beta -1a FBS-free/HSA-free, RNF INN or Proposed INN: Interferon beta -1a	Serono International SA	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
402	EUCTR2006-002982-38-CZ (EUCTR)	03/11/2006	15/09/2006	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)	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 S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	480	Phase 3	Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
403	EUCTR2006-000704-17-GB (EUCTR)	19/10/2006	10/05/2006	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1	Relapsing-remitting multiple sclerosis (RRMS)	Product Code: FTY720 INN or Proposed INN: Fingolimod Product Name: Interferon beta -1a INN or Proposed INN: interferon beta -1a Product Code: FTY720 INN or Proposed INN: Fingolimod	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	1275	Phase -	Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
404	EUCTR2006-000704-17-IT (EUCTR)	15/09/2006	06/11/2009	A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302	A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302	Relapsing-remitting multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245	Product Name: fingolimod Product Code: FTY720D Product Name: fingolimod Product Code: FTY720D INN or Proposed INN: Interferon beta -1a	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	1275		Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
405	EUCTR2006-000704-17-AT (EUCTR)	08/09/2006	12/07/2006	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302	Relapsing-remitting multiple sclerosis (RRMS)	Product Code: FTY720 INN or Proposed INN: Fingolimod	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	1275		Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;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
406	EUCTR2004-001286-17-PT (EUCTR)	08/09/2006	23/03/2006	Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis	Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis	Relapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity MedDRA version: 7.0;Level: PT;Classification code 10028245	Product Name: Mitoxantrone Product Code: N/A	Fundación Española de Esclerosis Múltiple (FEDEM)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		Portugal
407	EUCTR2005-005751-18-GB (EUCTR)	07/09/2006	17/02/2006	A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study	A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study	Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.	Trade Name: Rebif 44 Product Name: Rebif 44 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Trade Name: Rebif 22 Product Name: Rebif 22 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Product Name: Betaferon 500mcg Product Code: Betaferon 500mcg INN or Proposed INN: Interferon beta 1b	UCL Biomedicine R&D Unit	NULL	Not Recruiting			Female: yes Male: yes	100		United Kingdom
408	EUCTR2006-000704-17-DE (EUCTR)	21/08/2006	12/06/2006	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302	A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302	Relapsing-remitting multiple sclerosis (RRMS)	Product Code: FTY720 INN or Proposed INN: Fingolimod	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	1275	Phase -	Portugal;Hungary;United Kingdom;Germany;Belgium;Spain;Italy;Greece;Austria
409	NCT00288626 (ClinicalTrials.gov)	July 2006	7/2/2006	High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study	A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis	Relapsing-Remitting Multiple Sclerosis	Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone;Drug: Carmustine , etoposide, cytarabine, and melphalan (BEAM);Procedure: Autologous hematopoietic stem cell transplant	National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN)	Completed	18 Years	60 Years	All	25	Phase 2	United States
410	EUCTR2004-000555-42-PT (EUCTR)	26/01/2006	04/11/2005	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	Multiple sclerosis	Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide	Aventis Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	870		Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;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
411	EUCTR2004-000555-42-DK (EUCTR)	12/12/2005	23/01/2008	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term:	Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide	Sanofi-aventis US, Inc	NULL	Not Recruiting			Female: yes Male: yes	1080		Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden
412	NCT00127075 (ClinicalTrials.gov)	June 2005	4/8/2005	POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis	POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis	Multiple Sclerosis	Drug: nomegestrol acetate;Drug: estradiol;Drug: placebo	Hospices Civils de Lyon	NULL	Active, not recruiting	18 Years	50 Years	Female	300	Phase 3	France
413	NCT00942591 (ClinicalTrials.gov)	May 2005	17/7/2009	Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b	Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis.	Multiple Sclerosis	Drug: Interferon beta 1b;Drug: Atorvastatin	University Hospital Inselspital, Berne	CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel	Completed	18 Years	55 Years	Both	77	Phase 2	Switzerland
414	NCT01142492 (ClinicalTrials.gov)	January 2005	10/6/2010	A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif®)	Postmarketing Surveillance Study on the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis With Interferon Beta 1a (Rebif®)	Relapsing-Remitting Multiple Sclerosis	Drug: Interferon beta -1a	Merck KGaA	NULL	Completed	N/A	N/A	Both	403	N/A	NULL
415	EUCTR2004-000555-42-IT (EUCTR)	30/12/2004	23/11/2004	A randomized, double-blind, placebo-controlled, parallel-group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO	A randomized, double-blind, placebo-controlled, parallel-group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO	Multiple sclerosis with relapses 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: TERIFLUNOMIDE Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE	sanofi-aventis Recherche & De`veloppement	NULL	Not Recruiting			Female: yes Male: yes	870		Portugal;Estonia;Czech Republic;Denmark;Norway;United Kingdom;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
416	EUCTR2004-000555-42-AT (EUCTR)	02/12/2004	28/10/2004	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses	Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide	Sanofi-Aventis US, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1080		Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;United Kingdom;Italy;Sweden
417	EUCTR2004-000555-42-NO (EUCTR)	22/11/2004	27/09/2004	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO	A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO	Multiple sclerosis	Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide	Sanofi-aventis US, Inc	NULL	Not Recruiting			Female: yes Male: yes	1080		Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;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

NCT04601142
(ClinicalTrials.gov)

October 31, 2020

15/10/2020

Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism

Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study

Glucocorticoid Resistance;Gene;Neuromyelitis Optica

Drug: Methylprednisolone

Beijing Tongren Hospital

NULL

Recruiting

16 Years

80 Years

All

350

China

EUCTR2019-004980-36-LT
(EUCTR)

22/10/2020

25/05/2020

Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis

A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2)

Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE

Merck Healthcare KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

930

Phase 3

Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Latvia;Kuwait;Tunisia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden

EUCTR2020-000647-30-LT
(EUCTR)

22/10/2020

14/09/2020

Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)

A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES

Non-relapsing 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 Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan

NCT04480853
(ClinicalTrials.gov)

October 12, 2020

17/7/2020

Safety and Efficacy Study of Fingolimod in Taiwanese Adults (= 20years) With Relapsing Remitting Multiple Sclerosis

A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)

Multiple Sclerosis

Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Recruiting

20 Years

N/A

All

Phase 4

Taiwan

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04203498
(ClinicalTrials.gov)

October 1, 2020

17/12/2019

Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis

A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients With Spasticity Due to Multiple Sclerosis

Multiple Sclerosis (MS)

Drug: Nabiximols;Drug: Placebo

GW Pharmaceuticals Ltd.

NULL

Recruiting

18 Years

N/A

All

446

Phase 3

Poland

EUCTR2020-000647-30-DE
(EUCTR)

16/09/2020

29/06/2020

Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)

A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES

Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan;United States;Belarus

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

EUCTR2019-004980-36-SK
(EUCTR)

31/07/2020

27/05/2020

Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis

Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE

Merck Healthcare KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

930

Phase 3

Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Kuwait;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-000620-34-DE
(EUCTR)

06/05/2020

08/11/2019

Imatinib treatment for Multiple Sclerosis (MS) Relapses

Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS

Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

INN or Proposed INN: IMATINIB MESILATE
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE

Department of Clinical Neuroscience, Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

Germany;Sweden

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

EUCTR2019-002625-29-GB
(EUCTR)

16/03/2020

18/06/2020

A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis

A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis - Study in MS patient Naïve to treatment with Nabiximols

Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Sativex Oromucosal Spray
Product Name: Sativex Oromucosal Spray
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL

GW Pharma Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Poland;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

EUCTR2019-002625-29-PL
(EUCTR)

14/01/2020

21/11/2019

A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis

A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis

Trade Name: Sativex Oromucosal Spray
Product Name: Nabiximols - Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL

GW Pharma Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Poland;United Kingdom

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

NCT04115488
(ClinicalTrials.gov)

October 1, 2019

10/9/2019

Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®

Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

Relapsing-Remitting Multiple Sclerosis (RRMS)

Biological: Intravenous (IV) infusions

Polpharma Biologics S.A.

NULL

Active, not recruiting

18 Years

60 Years

All

260

Phase 3

Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine

EUCTR2018-004751-20-HR
(EUCTR)

18/09/2019

02/12/2019

A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis

Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope

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]

Product Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB

Polpharma Biologics S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 3

Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of

EUCTR2018-004751-20-PL
(EUCTR)

22/07/2019

25/04/2019

A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis

Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope

Product Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB

Polpharma Biologics S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 3

Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, 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

NCT03983252
(ClinicalTrials.gov)

July 2019

31/5/2019

Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis

Effect of Alemtuzumab on Microglial Activation Assessed Using Novel [F-18]-Based Positron Emission Tomography (PET) Ligand in Multiple Sclerosis

Multiple Sclerosis

Drug: [F-18]PBR06

Brigham and Women's Hospital

Genzyme, a Sanofi Company

Not yet recruiting

18 Years

60 Years

All

Phase 1;Phase 2

United States

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

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

EUCTR2012-000541-12-HR
(EUCTR)

23/04/2019

17/05/2019

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT

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

Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Greece;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Australia;Denmark;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04408742
(ClinicalTrials.gov)

April 15, 2019

26/5/2020

Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple Sclerosis

The Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple Sclerosis

Multiple Sclerosis;Menstrual Pain;Anxiety;Fatigue;Neurologic Symptoms

Other: pain;Other: fatigue;Other: anxiety;Other: position sense;Other: balance;Other: dual task performance

Ankara Yildirim Beyazit University

NULL

Completed

26 Years

49 Years

Female

Turkey

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

NCT04286828
(ClinicalTrials.gov)

March 25, 2019

23/2/2020

Position Sense, Balance, and Dual Task Performance at the Menstrual Cycle in Females With Multiple Sclerosis

An Investigation of Knee Position Sense, Balance, and Dual Task Performance in Different Phases of Menstrual Cycle in Females With Multiple Sclerosis

Multiple Sclerosis;Neurologic Symptoms;Menstrual Cycle

Other: Position Sense;Other: Balance;Other: Dual Task Performance

Ankara Yildirim Beyazit University

NULL

Completed

26 Years

49 Years

Female

Turkey

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

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

No.

TrialID

Date_
enrollment

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

EUCTR2017-004703-51-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

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

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

No.

TrialID

Date_
enrollment

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-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

EUCTR2018-001896-19-BG
(EUCTR)

17/12/2018

11/10/2018

Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS)

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: VIDOFLUDIMUS CALCIUM
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Product Name: VIDOFLUDIMUS CALCIUM
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

Poland;Ukraine;Romania;Bulgaria

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-002632-17-GB
(EUCTR)

25/07/2018

06/02/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Trade Name: Mavenclad ®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Netherlands;Sweden;United Kingdom

EUCTR2016-004719-10-FI
(EUCTR)

25/07/2018

12/06/2018

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT

relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden

EUCTR2017-002632-17-PT
(EUCTR)

16/07/2018

19/04/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Trade Name: Mavenclad ®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

EUCTR2017-002632-17-AT
(EUCTR)

11/07/2018

05/01/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

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

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

EUCTR2018-000721-31-SE
(EUCTR)

04/07/2018

24/04/2018

A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis.

RItuximab Long-Term DOSE Trial in Multiple Sclerosis – RIDOSE-MSA randomized trial of long-term dosage of rituximab in multiple sclerosisThe RIDOSE-MS trial is a multi-centre trial of long-term treatment with rituximab in MS, randomised between two different dosing regimens. Population: Patients with RRMS that has completed the RIFUND-MS trial in either the rituximab or DMF arm. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Intervention: Treatment with rituximab (Mabthera®) 500 mg every six months. Both the previous rituximab and DMF arms from the RIFUND trial will be treated with rituximab in the RIDOSE trial.Control: After one year of treatment in RIDOSE-MS, patients will be randomised 1:1 to either continue with 500 mg every 6 months or 500 mg every 12 months and continue on this treatment schedule for another 3 years.Outcome: Primary outcome will be the proportion of patients remaining with no evidence of disease activity (NEDA) -3 over the randomised period of 3 years. As secondary endpoints progression of disability, brain atrophy, cognitive function and level of serum Neurofilament-Light will be evaluated. In addition, Patient-related outcome scales measuring fatigue, work ability and treatment satisfaction will be analysed. - RIDOSE-MS

Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB

Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

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

EUCTR2016-004719-10-PT
(EUCTR)

02/07/2018

12/02/2018

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

EUCTR2017-002632-17-BE
(EUCTR)

24/05/2018

01/02/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

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

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

EUCTR2017-002632-17-NL
(EUCTR)

14/05/2018

27/02/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

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

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

NCT03498131
(ClinicalTrials.gov)

May 9, 2018

6/4/2018

Melatonin in Patients With Multiple Sclerosis (MS).

Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)

Relapsing Remitting Multiple Sclerosis

Drug: 3 mg Melatonin;Drug: 5 mg Melatonin

Providence Health & Services

NULL

Recruiting

18 Years

65 Years

All

Early Phase 1

United States

EUCTR2012-000541-12-BE
(EUCTR)

07/05/2018

09/02/2018

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-004719-10-GB
(EUCTR)

26/04/2018

22/05/2018

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden

EUCTR2017-002632-17-CZ
(EUCTR)

25/04/2018

29/01/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Trade Name: Mavenclad ®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

EUCTR2018-000620-34-SE
(EUCTR)

24/04/2018

14/03/2018

Imatinib treatment for Multiple Sclerosis (MS) Relapses

Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS

Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

INN or Proposed INN: IMATINIB MESILATE
Trade Name: Solu-Medrol
Product Name: Solu-Medrol
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE

Department of Clinical Neuroscience, Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

Sweden

EUCTR2017-002632-17-SE
(EUCTR)

18/04/2018

17/01/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

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

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

EUCTR2017-002632-17-FR
(EUCTR)

10/04/2018

07/02/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Trade Name: Mavenclad ®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;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

EUCTR2016-004719-10-HR
(EUCTR)

27/03/2018

12/04/2018

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

EUCTR2017-002632-17-DK
(EUCTR)

21/03/2018

01/02/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

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

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Sweden

EUCTR2017-002632-17-ES
(EUCTR)

16/03/2018

25/01/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Trade Name: Mavenclad ®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

EUCTR2017-001176-31-PT
(EUCTR)

12/03/2018

01/03/2018

A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Clinically-isolated syndrome (CIS) and 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B

Bayer AG

,NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Norway;Sweden

EUCTR2017-002632-17-FI
(EUCTR)

05/03/2018

05/02/2018

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Trade Name: Mavenclad ®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;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

EUCTR2017-002632-17-HU
(EUCTR)

26/02/2018

28/12/2017

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Trade Name: Mavenclad ®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

EUCTR2017-002632-17-LT
(EUCTR)

30/01/2018

21/12/2017

A Quality of Life Study for People with Relapsing Multiple Sclerosis

A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

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

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

445

Phase 4

Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden

EUCTR2016-004719-10-LV
(EUCTR)

30/01/2018

10/11/2017

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

EUCTR2016-004719-10-BG
(EUCTR)

24/01/2018

01/11/2017

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden

EUCTR2016-004719-10-CZ
(EUCTR)

22/01/2018

29/09/2017

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-004719-10-HU
(EUCTR)

11/01/2018

20/11/2017

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

EUCTR2016-004719-10-LT
(EUCTR)

29/12/2017

04/12/2017

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

EUCTR2017-003328-56-GB
(EUCTR)

19/12/2017

31/10/2017

MS-STAT2 - Multiple Sclerosis – Simvastatin Trial 2

A phase 3 randomised, double blind, clinical trial investigating the effectiveness of repurposed simvastatin compared to placebo, in secondary progressive multiple sclerosis, in slowing the progression of disability - MS-STAT2

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: Simvastatin 40 mg film-coated tablets
Product Name: Simvastatin 40 mg film-coated tablets
INN or Proposed INN: Simvastatin
Trade Name: Simvastatine Sandoz 40 mg filmomhulde tabletten
Product Name: Simvastatine Sandoz 40 mg filmomhulde tabletten
INN or Proposed INN: Simvastatin
Trade Name: SimvaHEXAL® 40 mg Filmtabletten
Product Name: SimvaHEXAL® 40 mg Filmtabletten
INN or Proposed INN: Simvastatin
Trade Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG
Product Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG
INN or Proposed INN: Simvastatin
Trade Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película
Product Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película
INN or Proposed INN: Simvastatin
Trade Name: Sivatin 40 mg film-coated tablets
Product Name: Sivatin 40 mg film-coated tablets
INN or Proposed INN: Simvastatin
Trade Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten
Product Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten
INN or Proposed INN: Simvastatin

University College London Comprehensive Clinical Trials Unit

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1180

Phase 3

United Kingdom

EUCTR2017-001176-31-CZ
(EUCTR)

07/12/2017

03/08/2017

A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B

Bayer AG

,NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden

EUCTR2017-001176-31-FR
(EUCTR)

07/12/2017

16/01/2018

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Clinically-isolated syndrome (CIS) and 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Bayer AG

,NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;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

EUCTR2016-004719-10-PL
(EUCTR)

02/12/2017

24/08/2017

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

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

NCT03347370
(ClinicalTrials.gov)

November 27, 2017

16/11/2017

A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis

Subcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice Setting

Multiple Sclerosis, Relapsing-Remitting

Drug: SC Peginterferon beta-1a;Drug: SC interferon beta-1a;Drug: SC interferon beta-1b

Biogen

AMS Advanced Medical Services GmbH

Completed

18 Years

N/A

All

626

Germany

EUCTR2017-001176-31-GB
(EUCTR)

06/11/2017

21/07/2017

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Bayer AG

,NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-001176-31-DK
(EUCTR)

25/10/2017

14/08/2017

A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Bayer AG

,NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden

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

EUCTR2016-004719-10-SE
(EUCTR)

04/10/2017

28/07/2017

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

EUCTR2012-000541-12-FI
(EUCTR)

03/10/2017

17/08/2017

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

EUCTR2016-004719-10-ES
(EUCTR)

02/10/2017

04/07/2017

A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.

Actelion Pharmaceuticals Ltd.

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

EUCTR2012-000541-12-BG
(EUCTR)

28/09/2017

04/07/2017

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

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

EUCTR2017-001176-31-ES
(EUCTR)

20/09/2017

12/07/2017

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Bayer AG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden;Portugal;Slovenia

EUCTR2017-001176-31-FI
(EUCTR)

14/09/2017

10/08/2017

A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Bayer AG

,NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden

EUCTR2017-001176-31-AT
(EUCTR)

07/09/2017

26/07/2017

A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Bayer AG

,NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;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

EUCTR2012-000541-12-PL
(EUCTR)

05/09/2017

27/07/2017

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

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

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

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

NCT03232073
(ClinicalTrials.gov)

July 17, 2017

20/7/2017

Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

Multicenter, Non-comparative Extension to Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: Ponesimod

Actelion

NULL

Active, not recruiting

18 Years

65 Years

All

800

Phase 3

United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

NCT02903537
(ClinicalTrials.gov)

July 6, 2017

21/7/2016

Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS)

Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS)

Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Chronic Progressive

Drug: Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3);Drug: Interferon-beta

Fundació Institut Germans Trias i Pujol

Clinica Universidad de Navarra, Universidad de Navarra

Unknown status

18 Years

60 Years

All

Phase 1

Spain

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

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

EUCTR2012-000541-12-FR
(EUCTR)

13/06/2017

17/07/2017

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

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

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

100

NCT02907177
(ClinicalTrials.gov)

March 30, 2017

25/8/2016

Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

Multiple Sclerosis

Drug: Ponesimod;Other: Placebo

Actelion

NULL

Terminated

18 Years

55 Years

All

136

Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;Russian Federation;Spain;Switzerland;United Kingdom;Croatia;Czech Republic;Finland;Norway

No.

TrialID

Date_
enrollment

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

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]

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

102

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

103

EUCTR2012-000541-12-GR
(EUCTR)

21/12/2016

24/08/2016

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

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

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

104

EUCTR2012-000541-12-PT
(EUCTR)

05/12/2016

19/07/2016

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

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

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

105

NCT03561402
(ClinicalTrials.gov)

December 1, 2016

7/6/2018

Biomarkers and Disease Activity in Patients Treated With Teriflunomide (Aubagio)

Association of Possible Biomarkers With Disease Activity in Patients Treated With Teriflunomide (Aubagio)

Multiple Sclerosis, Relapsing-Remitting

Drug: Teriflunomide

McGill University

NULL

Unknown status

18 Years

55 Years

All

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

106

EUCTR2012-000541-12-ES
(EUCTR)

21/11/2016

11/08/2016

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

107

EUCTR2016-002180-33-PL
(EUCTR)

16/11/2016

14/07/2016

Multiple sclerosis therapy with transdermal myelin peptide stimulation.

relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: SMderpept
INN or Proposed INN: PLP peptide
INN or Proposed INN: MBP peptide
INN or Proposed INN: MOG peptide
Product Name: SMderpept
INN or Proposed INN: PLP peptide
INN or Proposed INN: MBP peptide
INN or Proposed INN: MOG peptide
Product Name: Avonex
INN or Proposed INN: Interferon beta 1-A
Other descriptive name: INTERFERON BETA -1A

Centrum Neurologii Krzysztof Selmaj

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 2

Poland

108

EUCTR2012-000541-12-DE
(EUCTR)

15/11/2016

06/07/2016

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

109

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

110

EUCTR2012-000541-12-DK
(EUCTR)

07/11/2016

20/07/2016

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

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

EUCTR2015-005419-33-LV
(EUCTR)

03/11/2016

11/08/2016

Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing 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: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1313

Phase 3

Portugal;United States;United Arab Emirates;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany

112

EUCTR2012-000541-12-AT
(EUCTR)

02/11/2016

22/07/2016

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

113

EUCTR2015-003471-30-NL
(EUCTR)

02/11/2016

26/04/2016

A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis

A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS

Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Portugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of

114

EUCTR2016-001515-20-IT
(EUCTR)

20/10/2016

07/02/2018

EFFECT OF TERIFLUNOMIDE ON T CELL SUBPOPULATIONS INPERIPHERAL BLOOD FROM RRMS PATIENTS - nd

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]

Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) - 28 COMPRESSE
Product Name: teriflunomide
Product Code: nd

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Italy

115

EUCTR2015-005419-33-FR
(EUCTR)

14/10/2016

12/01/2017

Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing 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: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

1313

Phase 3

Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;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

116

EUCTR2016-003073-18-GB
(EUCTR)

29/09/2016

16/09/2016

A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body

A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)

The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Celgene International II Sàrl

NULL

Not Recruiting

Female: no
Male: yes

Phase 1

United Kingdom

117

EUCTR2015-003471-30-PL
(EUCTR)

23/09/2016

15/07/2016

A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Portugal;United States;Czech Republic;Taiwan;Canada;Malaysia;Poland;Romania;Turkey;Netherlands;Italy;Korea, Republic of

118

EUCTR2012-000541-12-HU
(EUCTR)

08/09/2016

21/07/2016

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

119

EUCTR2012-000541-12-CZ
(EUCTR)

29/08/2016

22/07/2016

Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

120

EUCTR2015-000507-44-LT
(EUCTR)

11/07/2016

16/05/2016

A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis

Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;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

121

EUCTR2015-000507-44-DE
(EUCTR)

29/06/2016

23/02/2016

A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis

Trade Name: Dysport ®
Product Name: Dysport ®
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX
Trade Name: Dysport ®
Product Name: Dysport ®
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand

122

EUCTR2015-003471-30-IT
(EUCTR)

30/05/2016

07/04/2016

A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis

Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify

Trade Name: DYSPORT ®
Product Name: DYSPORT ®
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX
Trade Name: DYSPORT ®
Product Name: DYSPORT ®
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX

Ipsen Innovation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

408

Phase 3

Portugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of

123

EUCTR2015-003471-30-CZ
(EUCTR)

27/05/2016

16/03/2016

A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis

Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

408

Phase 3

Portugal;United States;Taiwan;Czech Republic;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of

124

EUCTR2015-004059-29-EE
(EUCTR)

16/05/2016

22/02/2016

Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis

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 - CHANGE-MS

Multiple Sclerosis (MS)
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: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available

GeNeuro SA

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 2

Poland;Croatia;Bulgaria;Germany;Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary

125

EUCTR2015-003471-30-PT
(EUCTR)

09/05/2016

08/03/2016

A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

United States;Portugal;Taiwan;Czech Republic;Canada;Poland;Malaysia;Turkey;Romania;Netherlands;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

126

EUCTR2015-000507-44-ES
(EUCTR)

04/05/2016

18/03/2016

A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis

Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

408

Phase 3

Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand

127

NCT02749396
(ClinicalTrials.gov)

May 2, 2016

20/4/2016

EPID Multiple Sclerosis Pregnancy Study

Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon ß - a Register-based Study in the Nordic Countries

Multiple Sclerosis

Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG;Drug: Extavia (interferon beta-1b), Novartis Pharma AG;Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd;Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd;Drug: Avonex (interferon beta-1a), Biogen Idec Ltd;Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046);Other: No MSDMDs therapy (control)

Bayer

EPID Research;Biogen;Merck Serono Europe Ltd;Novartis Pharmaceuticals

Completed

N/A

Female

2089

Finland

128

NCT02649985
(ClinicalTrials.gov)

May 2, 2016

6/1/2016

Microglial Activation Positron Emission Tomography (PET) Brain Imaging in Multiple Sclerosis and Alzheimer's Disease

Multiple Sclerosis;Alzheimer's Disease

Drug: [F-18]PBR06;Drug: [C-11]PBR28

Brigham and Women's Hospital

NULL

Recruiting

18 Years

85 Years

All

105

Phase 1;Phase 2

United States

129

NCT03566251
(ClinicalTrials.gov)

May 1, 2016

11/6/2018

Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis

The Investigation of the Relationship Between Core Stability and Trunk Position Sense With Balance and Functional Mobility in Patients With Multiple Sclerosis

Physical Therapy

Other: Balance;Other: Functional mobility;Other: Core stability;Other: Trunk position sense

Ankara Yildirim Beyazit University

NULL

Completed

18 Years

65 Years

All

N/A

Turkey

130

EUCTR2015-000507-44-FR
(EUCTR)

29/04/2016

21/03/2016

A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

408

Phase 3

Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;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

131

EUCTR2015-000507-44-BE
(EUCTR)

31/03/2016

08/03/2016

A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis

Ipsen Innovation

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand

132

NCT02601131
(ClinicalTrials.gov)

February 2016

28/10/2015

Post-transfusion Platelet Count

Leukemia;Multiple Sclerosis

Biological: Platelet transfusion

Region Skane

NULL

Completed

18 Years

N/A

Both

N/A

Sweden

133

EUCTR2012-000540-10-PT
(EUCTR)

23/10/2015

21/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM

Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio ®
Product Name: Aubagio ®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

Hungary;United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden

134

EUCTR2012-000540-10-LT
(EUCTR)

21/10/2015

17/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden

135

EUCTR2012-000540-10-HU
(EUCTR)

15/10/2015

19/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio ®
Product Name: Aubagio ®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden

No.

TrialID

Date_
enrollment

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

EUCTR2012-000540-10-SE
(EUCTR)

07/10/2015

14/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio ®
Product Name: Aubagio ®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

137

EUCTR2012-000540-10-GR
(EUCTR)

02/10/2015

05/11/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

relapsing multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

138

NCT02606630
(ClinicalTrials.gov)

October 2015

13/11/2015

[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple Sclerosis

A [C-11]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT-555 on Central Nervous System Inflammation in Subjects With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

Drug: ABT-555

AbbVie

NULL

Terminated

18 Years

60 Years

All

Phase 1

United Kingdom

139

EUCTR2012-000540-10-LV
(EUCTR)

25/09/2015

14/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

140

EUCTR2012-000540-10-HR
(EUCTR)

23/09/2015

01/10/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

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

EUCTR2012-000540-10-FI
(EUCTR)

23/09/2015

19/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

142

EUCTR2012-000540-10-DE
(EUCTR)

23/09/2015

03/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio ®
Product Name: Aubagio ®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

143

EUCTR2012-000540-10-ES
(EUCTR)

21/09/2015

11/09/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

relapsing multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio ®
Product Name: Aubagio ®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT -128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Serbia;Portugal;Belarus;United States;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden

144

EUCTR2012-000540-10-CZ
(EUCTR)

15/09/2015

17/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

145

NCT02486640
(ClinicalTrials.gov)

September 8, 2015

15/6/2015

Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon

BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence

Multiple Sclerosis

Drug: Interferon beta -1b (Betaferon, BAY86-5046);Device: Betaconnect Autoinjector

Bayer

NULL

Completed

18 Years

N/A

All

162

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

146

EUCTR2012-000540-10-PL
(EUCTR)

25/08/2015

12/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio ®
Product Name: Aubagio ®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3

147

NCT03046251
(ClinicalTrials.gov)

August 2015

3/2/2017

Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

Multiple Sclerosis

Drug: Natalizumab

State University of New York at Buffalo

NULL

Recruiting

18 Years

N/A

Female

100

Phase 4

United States

148

NCT02542787
(ClinicalTrials.gov)

August 2015

4/9/2015

Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis

Spasticity in People With Multiple Sclerosis

Drug: VSN16R;Other: Placebo

Canbex Therapeutics Ltd

NULL

Completed

18 Years

70 Years

All

160

Phase 2

United Kingdom

149

NCT02632591
(ClinicalTrials.gov)

August 2015

14/12/2015

Use on Human Beings of Mix of Known Drugs for New Destination - MS Treatment

Use on Human Being of a Mix Between Very Well Known Drugs, Tested Upon Registered Trial n° NCT02606929, to Consider Effectiveness of Improvement After 45 Days

Multiple Sclerosis;Autoimmune Disease;Disseminated or Multiple Sclerosis Nos;Multiple Sclerosis, Acute Relapsing;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic Progressive

Drug: Tetracycline;Drug: statin;Drug: antimycotic;Drug: Fingolimod;Drug: copaxone

Università Popolare Homo & Natura

NULL

Completed

18 Years

65 Years

Both

Phase 1

Italy

150

EUCTR2012-000540-10-FR
(EUCTR)

31/07/2015

03/08/2015

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1100

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

151

NCT02425644
(ClinicalTrials.gov)

June 4, 2015

21/4/2015

Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: ponesimod;Drug: teriflunomide

Actelion

NULL

Completed

18 Years

55 Years

All

1133

Phase 3

152

EUCTR2013-002660-17-DK
(EUCTR)

02/06/2015

16/04/2015

Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis

Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS

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]

Trade Name: Gilenya
Product Name: Fingolmod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

281

Phase 2

Portugal;France;Canada;Finland;Poland;Spain;Denmark;Germany;Italy;United Kingdom;Switzerland

153

EUCTR2015-001197-18-NO
(EUCTR)

20/05/2015

15/04/2015

The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events.

multiple sclerosis;Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

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

Biogen Idec Norway

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Norway

154

NCT02495766
(ClinicalTrials.gov)

May 11, 2015

3/6/2015

Autologous Mesenchymal Stromal Cells for Multiple Sclerosis

Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis

Drug: XCEL-MC-ALPHA;Drug: Placebo

Banc de Sang i Teixits

Vall d'Hebron Research Institute (VHIR)

Completed

18 Years

60 Years

All

Phase 1;Phase 2

Spain

155

NCT02419378
(ClinicalTrials.gov)

May 2015

31/3/2015

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential

Multiple Sclerosis, Relapsing-Remitting

Drug: Alemtuzumab

University Hospital Muenster

Genzyme, a Sanofi Company

Recruiting

18 Years

55 Years

Both

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

156

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

157

NCT02638038
(ClinicalTrials.gov)

February 2015

16/12/2015

This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for = 3 Years

A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing Remitting

Drug: INT131

InteKrin Therapeutics, Inc.

NULL

Completed

18 Years

50 Years

All

228

Phase 2

NULL

158

EUCTR2014-004412-11-GB
(EUCTR)

16/01/2015

19/11/2014

The purpose of this study is to examine the safety and efficacy of VSN16R and the performance in treating spasticity (tightness, stiffness or pull of muscles) in patients with Multiple Sclerosis (MS).

Multiple Sclerosis
MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: VSN16R 100mg
Product Code: VSN16R
INN or Proposed INN: VSN16R
Other descriptive name: (R) 3-(5-Dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1- methylethyl) benzamide

Canbex Therapeutics Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United Kingdom

159

NCT02606929
(ClinicalTrials.gov)

January 2015

12/11/2015

Use of Well Known Drugs for New Destination - MS Improvement (MSNT)

Expanded Access Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Multiple Sclerosis Not Responding With Commonly Used Treatments

Multiple Sclerosis;Autoimmune Diseases;Disseminated or Multiple Sclerosis Nos;Multiple Sclerosis, Acute Relapsing;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic Progressive

Drug: Tetracycline - Statin - Antimycotic

Università Popolare Homo & Natura

NULL

Temporarily not available

18 Years

65 Years

Both

Phase 0

Italy

160

EUCTR2014-000709-10-DE
(EUCTR)

19/12/2014

13/10/2014

Investigation on how alemtuzumab acts in patients with relapsing remitting multiple sclerosis.

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential - ALAIN01

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]

Trade Name: LEMTRADA 12 mg Konzentrat zur Herstellung einer Infusionslösung
INN or Proposed INN: Alemtuzumab
Other descriptive name: ALEMTUZUMAB

Universitätsklinikum Münster

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

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

161

EUCTR2014-003209-14-FR
(EUCTR)

01/09/2014

18/06/2015

ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS

ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFF

MULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: TYSABRI 300 mg solution à diluer pour perfusion
INN or Proposed INN: NATALIZUMAB

Hôpitaux Universitaires de Strasbourg

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

162

NCT02287948
(ClinicalTrials.gov)

September 2014

6/11/2014

Wii FIT Balance Board to Recording Balance Parameters in Multiple Sclerosis Subjects

Validation Study for Using Wii FIT Balance Board to Recording Balance Parameters in Healthy Subjects and Multiple Sclerosis Subjects

Postural Balance;Multiple Sclerosis

Device: Nintendo Wii Fit Balance Board

University Hospital of Ferrara

NULL

Completed

18 Years

80 Years

Both

N/A

Italy

163

NCT02273635
(ClinicalTrials.gov)

September 2014

3/10/2014

Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS

Controlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple Sclerosis

Primary Progressive Multiple Sclerosis;Multiple Sclerosis, Secondary Progressive

Drug: Andrographolides;Drug: placebo

Innobioscience SpA

Pontificia Universidad Catolica de Chile;University of Chile;Universidad Austral de Chile

Recruiting

18 Years

70 Years

Both

Phase 1;Phase 2

Chile

164

NCT02159573
(ClinicalTrials.gov)

July 2014

19/5/2014

Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)

A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)

Relapsing-Remitting Multiple Sclerosis

Biological: natalizumab;Drug: dimethyl fumarate

Biogen

NULL

Completed

18 Years

N/A

Both

530

N/A

United States

165

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-005249-12-ES
(EUCTR)

03/06/2014

01/04/2014

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 - TERIKIDS

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]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 3

Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China

167

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

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

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

168

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

169

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

170

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

171

NCT01892345
(ClinicalTrials.gov)

April 11, 2014

20/6/2013

A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)

Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder

Drug: Eculizumab;Drug: Placebo

Alexion Pharmaceuticals

NULL

Terminated

18 Years

N/A

All

143

Phase 3

United States;Argentina;Australia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Canada;Colombia;Czech Republic;France;Singapore

172

EUCTR2012-000734-19-ES
(EUCTR)

10/04/2014

10/01/2014

Bone marrow cell treatment as treatment of multiple sclerosis

Treatment of autologous mesenchymal stem cells derived from bone marrow as a potential therapeutic strategy for the treatment of multiple sclerosis - EMMES

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: XCEL-MC-ALPHA
Product Code: XCEL-MC-ALPHA
INN or Proposed INN: Autologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved
Other descriptive name: Mesenchymal Stem Cells

Banc de Sang i Teixits

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

173

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

174

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

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]

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

175

NCT02227524
(ClinicalTrials.gov)

April 2014

20/8/2014

Trekking Poles to Aid Multiple Sclerosis Gait Impairment

Multiple Sclerosis

Other: No device;Device: Single-point cane (SPC);Device: Four-point cane (FPC);Device: Trekking pole (TP).

Rowan University

NULL

Completed

18 Years

64 Years

All

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

176

EUCTR2012-004019-29-DE
(EUCTR)

19/09/2013

06/05/2013

Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis

A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis

Relapsing multiple sclerosis
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]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2

Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden

177

EUCTR2012-005262-35-GB
(EUCTR)

14/08/2013

11/06/2013

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11

Clinically isolated syndrome (CIS) and 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

468

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

178

EUCTR2012-005262-35-IT
(EUCTR)

14/08/2013

25/06/2013

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: Recombinant interferon beta-1b

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

468

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

179

EUCTR2012-004019-29-PT
(EUCTR)

02/08/2013

03/06/2013

Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis

Relapsing 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: Secukinumab
Product Code: AIN457

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

380

Phase 2

Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden

180

JPRN-UMIN000010094

2013/08/01

01/04/2013

A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica

neuromyelitis optica

4.8mg/kg Sivelestat Sodium will administered constantly for 5 days in combination with 3 days intravenous methyl-prednisolone administration to sero-positive neuromyelitis optica patients who relapsed within 72 hours before starting treatment.

Tohoku University Hospital

NULL

Complete: follow-up complete

20years-old

55years-old

Male and Female

Phase 1;Phase 2

Japan

No.

TrialID

Date_
enrollment

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

EUCTR2012-005262-35-AT
(EUCTR)

19/07/2013

02/04/2013

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: Recombinant interferon beta-1b

Bayer HealthCare AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

468

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

182

EUCTR2012-004019-29-CZ
(EUCTR)

18/07/2013

13/05/2013

Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2

Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden

183

EUCTR2012-005262-35-SI
(EUCTR)

10/07/2013

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: Recombinant interferon beta-1b

Bayer HealthCare AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

468

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

184

NCT01896700
(ClinicalTrials.gov)

July 2013

8/7/2013

Methylphenidate to Improve Balance and Walking in MS

Multiple Sclerosis

Drug: Methylphenidate;Drug: Placebo

Oregon Health and Science University

Portland VA Medical Center

Completed

20 Years

65 Years

All

Phase 2;Phase 3

United States

185

EUCTR2012-005262-35-ES
(EUCTR)

28/06/2013

13/06/2013

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

468

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;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

186

EUCTR2012-004019-29-SE
(EUCTR)

19/06/2013

12/04/2013

Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis

Product Name: Secukinumab
Product Code: AIN457

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2

Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden

187

EUCTR2012-004019-29-FI
(EUCTR)

19/06/2013

16/05/2013

Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis

Product Name: Secukinumab
Product Code: AIN457

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2

Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden

188

EUCTR2012-005262-35-FI
(EUCTR)

18/06/2013

25/04/2013

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: Recombinant interferon beta-1b

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

468

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

189

EUCTR2012-005262-35-CZ
(EUCTR)

13/06/2013

26/03/2013

A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: Recombinant interferon beta-1b

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

468

Phase 4

Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

190

NCT01651520
(ClinicalTrials.gov)

June 2013

25/7/2012

Prognosis Value of the Neuronal Damage in Early Multiple Sclerosis

Prognosis Value of the Neuronal Damage Detected by Positrons Emission Tomography (PET) With 11C-Flumazenil in Early Multiple Sclerosis.

Multiple Sclerosis

Drug: PET with 11C-Flumazenil

Assistance Publique - Hôpitaux de Paris

NULL

Active, not recruiting

18 Years

55 Years

All

N/A

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

191

EUCTR2012-004019-29-ES
(EUCTR)

24/05/2013

24/06/2013

Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB

Novartis Farmacéutica, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2

Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden

192

NCT01845584
(ClinicalTrials.gov)

May 2013

26/4/2013

Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.

NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.

Neuromyelitis Optica Spectrum Disorder

Drug: NPB-01

Nihon Pharmaceutical Co., Ltd

NULL

Completed

20 Years

N/A

All

Phase 2

Japan

193

EUCTR2012-004019-29-BE
(EUCTR)

29/04/2013

23/10/2012

Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis

Product Name: Secukinumab
Product Code: AIN457
Other descriptive name: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2

Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden

194

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

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

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

195

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

No.

TrialID

Date_
enrollment

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

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

197

EUCTR2012-003627-38-CZ
(EUCTR)

18/02/2013

12/11/2012

Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis

Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis

Relapsing Remitting 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]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

114

Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden

198

EUCTR2012-003627-38-BG
(EUCTR)

01/02/2013

21/11/2012

Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis

Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

114

Phase 2

Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden

199

NCT01772199
(ClinicalTrials.gov)

February 2013

17/1/2013

Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis

Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: GSK239512;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

50 Years

Both

131

Phase 2

Bulgaria;Canada;Czech Republic;Germany;Spain;Sweden;Ukraine;United Kingdom

200

EUCTR2012-003627-38-SE
(EUCTR)

30/01/2013

10/09/2012

Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis

Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

114

Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;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

201

EUCTR2012-003627-38-DE
(EUCTR)

24/01/2013

27/09/2012

Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis

Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis
MedDRA version: 15.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

114

Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden

202

EUCTR2012-003627-38-GB
(EUCTR)

15/01/2013

21/11/2012

Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis

Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis

Relapsing Remitting 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]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

114

Phase 2

Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden

203

EUCTR2012-003627-38-ES
(EUCTR)

17/12/2012

02/10/2012

Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis

Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis.

Product Code: GSK2395612
INN or Proposed INN: GSK239512
Product Code: GSK239512
INN or Proposed INN: GSK239512
Product Code: GSK239512
INN or Proposed INN: GSK239512
Product Code: GSK239512
INN or Proposed INN: GSK239512

GlaxoSmithKline, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

114

Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden

204

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

205

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

206

EUCTR2012-003056-36-IT
(EUCTR)

21/11/2012

15/10/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis

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
MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Siponimod
Product Code: BAF312A
INN or Proposed INN: siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod
Product Code: BAF312A
INN or Proposed INN: siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod
Product Code: BAF312A
INN or Proposed INN: siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod
Product Code: BAF312A
INN or Proposed INN: siponimod
Other descriptive name: BAF312 hemifumarate

NOVARTIS FARMA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Portugal;United States;Estonia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Australia;Bulgaria;Latvia;Germany;Sweden

207

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

208

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

209

EUCTR2012-003056-36-HU
(EUCTR)

31/10/2012

03/09/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis

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

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden

210

EUCTR2012-000957-30-CZ
(EUCTR)

11/09/2012

18/06/2012

BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis

BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis

Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS)
MedDRA version: 17.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: BOTOX ®
Product Name: BOTOX ®
Product Code: 9060X
INN or Proposed INN: Botulinum Toxin Type A

Allergan Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

184

Portugal;France;United States;Czech Republic;Canada;Poland;Belgium;Russian Federation;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

211

NCT01706055
(ClinicalTrials.gov)

September 2012

7/9/2012

Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)

Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®

Multiple Sclerosis

Biological: Interferon beta -1b (Betaseron, BAY86-5046)

Bayer

NULL

Completed

18 Years

N/A

All

629

N/A

Poland

212

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

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 I

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

213

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

214

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

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: 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

215

EUCTR2010-020328-23-PT
(EUCTR)

06/01/2012

17/11/2011

Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.

A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR

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]

Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono SA - Geneva, an affiliate of Merck KGaA

,NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 2

Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

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

217

EUCTR2010-020328-23-AT
(EUCTR)

23/11/2011

28/10/2011

Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.

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: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono SA - Geneva, an affiliate of Merck KGaA

,NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 2

Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands

218

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

219

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

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/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

220

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

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

No.

TrialID

Date_
enrollment

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

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

222

NCT01403376
(ClinicalTrials.gov)

September 2011

14/7/2011

Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide

Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference

Multiple Sclerosis

Drug: teriflunomide;Drug: Interferon-ß-1;Biological: Influenza vaccine

Sanofi

NULL

Completed

18 Years

59 Years

All

128

Phase 2

Austria;Canada;Germany;Russian Federation;Ukraine

223

EUCTR2010-020328-23-LV
(EUCTR)

19/07/2011

16/05/2011

Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.

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]

Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Latvia;Norway;Germany;Netherlands

224

EUCTR2011-001160-21-DE
(EUCTR)

18/07/2011

20/05/2011

Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide

Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVA

Multiple sclerosis
MedDRA version: 14.0;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: HMR1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
Trade Name: Mutagrip
Product Name: Mutagrip

sanofi-aventis recherche & developpement

NULL

Not Recruiting

Female: yes
Male: yes

120

Canada;Ukraine;Austria;Russian Federation;Germany

225

EUCTR2011-001160-21-AT
(EUCTR)

06/07/2011

31/05/2011

Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide

sanofi-aventis recherche & developpement

NULL

Not Recruiting

Female: yes
Male: yes

120

Germany;Russian Federation;Ukraine;Canada;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

226

NCT01451723
(ClinicalTrials.gov)

July 2011

11/10/2011

Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II

Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS

Multiple Sclerosis

Drug: Polyphenon E;Other: Placebo

Louisiana State University Health Sciences Center in New Orleans

National Center for Complementary and Integrative Health (NCCIH)

Terminated

18 Years

60 Years

All

Phase 2

United States

227

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

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

228

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

229

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

230

EUCTR2011-001956-12-CZ
(EUCTR)

25/05/2011

04/05/2011

Biological Efficacy of Interferon ß Therapy in Patients with Multiple Sclerosis

Monitoring of MxA mRNA Expression as a Marker of Rresponse to Interferon ß Therapy in Patients with Multiple Sclerosis.

To correlate bioactivity of IFNß reflected by level of MxA expression and clinical course of MS To measure expression of MxA protein in patients treated with IFNß depending on NAbs statusNAbs positive cohorts will be correlated NAbs titer with level of MxA expression, respectively if the MxA decrease is not preceding NAbs positivity. The MxA induction test will be tested.

Trade Name: Avonex ®
Product Name: Avonex ®
Product Code: EU/1/97/033/002
Trade Name: Betaferon ®
Product Name: Betaferon ®
Product Code: EU/1/95/003/005-010
Trade Name: Rebif 22®
Product Name: Rebif 22®
Product Code: EU/1/98/063/001-003
Trade Name: Rebif 44®
Product Name: Rebif 44®
Product Code: EU/1/98/063/004-006
Trade Name: Extavia ®
Product Name: Extavia ®
Product Code: EU/1/08/454/001-002, EU/1/08/454/005-007

University Hospital Motol

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

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

231

EUCTR2009-017978-21-IT
(EUCTR)

16/05/2011

05/01/2012

Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials

Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE). - PREMIERE

Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
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: Cladribine Tablet
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-CdA , 2-chloro-2'-deoxy-ß-D-adenosine

MERCK SERONO SA

NULL

Not Recruiting

Female: yes
Male: yes

2175

Phase 3

Portugal;United Arab Emirates;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;India;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United States Minor Outlying Islands;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Georgia;Germany;Sweden

232

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

233

EUCTR2010-020328-23-LT
(EUCTR)

09/05/2011

02/03/2011

Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.

Trade Name: Vigantol Oil
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: CHOLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands

234

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

235

EUCTR2010-020328-23-EE
(EUCTR)

26/04/2011

21/03/2011

Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment.

A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR

Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

236

EUCTR2010-020328-23-BE
(EUCTR)

01/04/2011

18/11/2010

A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: EMD 28162
INN or Proposed INN: CHOLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono SA-Geneva an affiliate of Merck KgaA, Darmstadt

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 2

Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy

237

EUCTR2010-023172-12-PT
(EUCTR)

30/03/2011

01/02/2011

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

Multiple sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

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

238

EUCTR2010-023172-12-DK
(EUCTR)

23/03/2011

26/04/2011

Multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

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;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

239

EUCTR2010-023172-12-GR
(EUCTR)

15/03/2011

27/01/2011

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
Other descriptive name: NA
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide

sanofi-aventis group

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

240

EUCTR2010-023172-12-GB
(EUCTR)

14/03/2011

20/12/2010

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-020328-23-IT
(EUCTR)

10/03/2011

07/02/2011

A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR

RELAPSING REMITTING MULTIPLE SCLEROSIS
MedDRA version: 9.1;Level: PT;Classification code 10063399

Trade Name: VIGANTOL OIL
INN or Proposed INN: Colecalciferol

MERCK SERONO SA

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 2

Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy

242

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

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

243

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

244

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]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

245

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

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

246

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

247

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

248

EUCTR2010-023172-12-BE
(EUCTR)

08/02/2011

29/11/2010

Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

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

Phase 3

Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

249

NCT02073474
(ClinicalTrials.gov)

February 2011

21/2/2014

An Observational Post-Marketing Safety Registry of Sativex®

An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex®

Multiple Sclerosis;Diabetes;Cancer;Neuropathic Pain

Drug: Sativex ®

GW Pharmaceuticals Ltd.

NULL

Completed

N/A

All

978

N/A

NULL

250

EUCTR2010-020328-23-DE
(EUCTR)

31/01/2011

27/10/2010

Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment.

A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR

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: Vigantol Oel
Product Name: Vigantol Oil
Product Code: EMD 28162
INN or Proposed INN: CHOLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

Portugal;Estonia;Finland;Lithuania;Austria;Italy;Switzerland;Belgium;Denmark;Germany;Latvia;Netherlands;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

251

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

252

EUCTR2010-023172-12-SK
(EUCTR)

26/01/2011

20/12/2010

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

Phase 3

Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

253

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]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

254

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

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

255

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

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

256

EUCTR2010-023172-12-IT
(EUCTR)

13/01/2011

08/02/2011

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 - ND

Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245

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;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

257

EUCTR2010-020328-23-NL
(EUCTR)

06/01/2011

16/09/2010

A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono The Netherlands - a division of Merck B.V.

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 2

Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy

258

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.

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

259

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

260

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

No.

TrialID

Date_
enrollment

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

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

262

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

263

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

264

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]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

265

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]

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

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-020328-23-DK
(EUCTR)

09/12/2010

08/11/2010

Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.

Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands

267

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

268

EUCTR2009-011470-15-NL
(EUCTR)

03/12/2010

03/06/2010

An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.

Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis

relapsing-remitting multiple sclerosis
MedDRA version: 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]

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden

269

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

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

270

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

271

EUCTR2009-015556-15-AT
(EUCTR)

19/11/2010

07/06/2010

A Multicenter, Randomized, Rater-Blind, 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: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA -1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA -1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

272

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

273

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

274

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

275

EUCTR2010-020328-23-FI
(EUCTR)

21/10/2010

27/08/2010

Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.

Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol , Vitamin D3

Merck Serono

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

276

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

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

277

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

278

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

279

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

280

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

No.

TrialID

Date_
enrollment

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

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

282

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

283

EUCTR2009-010788-18-ES
(EUCTR)

27/09/2010

08/01/2010

Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab.

Esclerosis Multiple de Recaida-Remision/Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MABCAMPATH 10 mg/ml concentrado para solución para perfusión
INN or Proposed INN: ALEMTUZUMAB
Other descriptive name: ALEMTUZUMAB

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

284

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

285

EUCTR2009-011470-15-PL
(EUCTR)

14/09/2010

25/05/2010

Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

No.

TrialID

Date_
enrollment

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

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

287

EUCTR2009-015556-15-GB
(EUCTR)

02/09/2010

17/03/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

288

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

289

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

290

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

No.

TrialID

Date_
enrollment

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

EUCTR2009-015556-15-DK
(EUCTR)

25/08/2010

17/06/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden

292

EUCTR2009-011470-15-DE
(EUCTR)

20/08/2010

08/04/2010

Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: ponesimod
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: ponesimod
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN:

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden

293

EUCTR2009-015556-15-DE
(EUCTR)

20/08/2010

19/03/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

294

EUCTR2009-015556-15-NL
(EUCTR)

13/08/2010

08/04/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe
Other descriptive name: INTERFERON BETA -1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA -1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

295

EUCTR2009-011470-15-BG
(EUCTR)

12/08/2010

30/04/2010

Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;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

296

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

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

297

EUCTR2009-011470-15-AT
(EUCTR)

03/08/2010

28/06/2010

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden

298

NCT00997438
(ClinicalTrials.gov)

August 2010

16/10/2009

Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

Multiple Sclerosis

Dietary Supplement: Lipoic Acid

Portland VA Medical Center

Oregon Health and Science University

Completed

18 Years

N/A

All

Phase 1

United States

299

EUCTR2009-015556-15-GR
(EUCTR)

13/07/2010

14/12/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

300

EUCTR2009-011470-15-HU
(EUCTR)

08/07/2010

01/06/2010

Product Name: Ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

No.

TrialID

Date_
enrollment

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

EUCTR2009-015556-15-PT
(EUCTR)

02/07/2010

30/03/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden

302

NCT01171209
(ClinicalTrials.gov)

July 2010

8/7/2010

REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients

Multiple Sclerosis

Drug: Interferon-beta and human leukocyte Interferon-a

Melinda Magyari

University of Copenhagen

Completed

18 Years

55 Years

Both

Phase 2

Denmark

303

EUCTR2009-011470-15-GB
(EUCTR)

22/06/2010

29/03/2010

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

Sweden;United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands

304

EUCTR2009-015556-15-IT
(EUCTR)

07/06/2010

A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND

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

Trade Name: TYSABRI
INN or Proposed INN: Natalizumab
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
Trade Name: REBIF
INN or Proposed INN: Interferon beta -1a
Trade Name: REBIF *SC 12SIR 6000000UI 22MCG
INN or Proposed INN: Interferon beta -1a

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

305

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

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

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;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

306

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

307

EUCTR2009-015556-15-ES
(EUCTR)

24/05/2010

24/03/2010

Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS

Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: TYSABRI 300 mg concentrado para solución para perfusión
INN or Proposed INN: NATALIZUMAB
Other descriptive name: NATALIZUMAB
Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada
INN or Proposed INN: GLATIRAMERO ACETATO
Other descriptive name: GLATIRAMER ACETATE
Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

308

NCT01093326
(ClinicalTrials.gov)

May 12, 2010

24/3/2010

Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis

Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis

Drug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mg

Actelion

NULL

Active, not recruiting

18 Years

55 Years

All

353

Phase 2

United States;Austria;Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Czech Republic

309

EUCTR2009-015556-15-FI
(EUCTR)

07/05/2010

24/02/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

310

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

No.

TrialID

Date_
enrollment

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

NCT01354665
(ClinicalTrials.gov)

May 2010

16/5/2011

Depression and Fatigue in MS Patients Treated With Betaferon.

The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis.

Multiple Sclerosis

Biological: Interferon beta -1b (Betaferon, BAY86-5046)

Bayer

NULL

Completed

18 Years

N/A

Both

567

N/A

Poland

312

EUCTR2009-011470-15-CZ
(EUCTR)

30/04/2010

29/03/2010

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden

313

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

314

EUCTR2009-011470-15-SE
(EUCTR)

12/04/2010

04/03/2010

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden

315

EUCTR2009-016824-29-DK
(EUCTR)

06/04/2010

25/02/2010

REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIR

Multiple Sclerosis
MedDRA version: 12.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Multiferon
INN or Proposed INN: HUMAN LEUCOCYTE INTERFERON-ALPHA
Other descriptive name: HUMAN LEUCOCYTE INTERFERON-ALPHA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA -1B
Other descriptive name: INTERFERON BETA -1B

Dansk Multipel Sclerose Center

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

No.

TrialID

Date_
enrollment

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

EUCTR2009-011470-15-FI
(EUCTR)

30/03/2010

09/02/2010

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

353

Phase 2

United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden

317

EUCTR2009-011088-35-DE
(EUCTR)

24/03/2010

05/02/2010

Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS

Patients with Multiple Sclerosis (MS) or Clinically isolated syndrome suggestive for MS (CIS) are investigated. The main objective is to conserve data about changes in the VIP/PACAP (vasoactive intestinal polypaptide/pituitary adenylate cyclase activating polypeptide) system in stresses patients who start a immunomodulatory treatment with glatiramer acetate (Copaxone).

Trade Name: Copaxone
Product Name: copaxone
Product Code: 52069.00.01
INN or Proposed INN: glatiramer acetate

Philipps-Universität Marburg

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

318

EUCTR2008-003706-33-GR
(EUCTR)

10/03/2010

12/03/2009

Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta -1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA -1A

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

642

Phase 3

Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece

319

EUCTR2009-012431-15-CZ
(EUCTR)

21/01/2010

02/12/2009

Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®.

Studie se zabývá lécbou hyperaktivního neurogeního detruzoru u pacientu, kterí trpí príznaky hyperaktivního mocového mechýre jako dusledek spinálního poranení nebo roztroušené sklerózy. K lécbe se pužívá botulinumotoxin. Ve studii se porovnávaní dve ruzné formy aplikace studjiního léku.

Trade Name: Botox
Other descriptive name: BOTULINUM TOXIN TYPE A

Krajská nemocnice Liberec, a.s.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Czech Republic

320

EUCTR2008-004954-34-AT
(EUCTR)

21/01/2010

09/12/2008

Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)

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: 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: Rebif
INN or Proposed INN: Interferon-beta 1a

Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

492

Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;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

321

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

322

NCT01101776
(ClinicalTrials.gov)

January 2010

8/4/2010

Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.

Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting

Multiple Sclerosis

Drug: Interferon beta -1a (Rebif)

Merck KGaA

Merck Serono Australia Pty Ltd

Completed

18 Years

N/A

Both

N/A

Australia

323

EUCTR2008-008554-23-SE
(EUCTR)

29/12/2009

26/06/2009

Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF

IFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation).
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: Rebif
Product Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

The Multiple Sclerosis Research Group, Department of Clinical Neuroscience

NULL

Not Recruiting

Female: yes
Male: yes

100

Sweden

324

NCT01051817
(ClinicalTrials.gov)

December 2009

19/1/2010

POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler

A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis

Relapsing-remitting Multiple Sclerosis;RRMS

Drug: AIN457;Drug: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

55 Years

All

Phase 2

Czech Republic;Russian Federation;Ukraine;Serbia;Sweden

325

EUCTR2009-013884-21-DE
(EUCTR)

18/11/2009

09/09/2009

A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)

Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.0;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: PEG -liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE

Enceladus Pharmaceuticals BV

NULL

Not Recruiting

Female: yes
Male: yes

Poland;Belgium;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

326

EUCTR2009-013884-21-BE
(EUCTR)

13/11/2009

10/09/2009

Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Belgium;Germany

327

EUCTR2006-003361-14-CZ
(EUCTR)

12/10/2009

05/05/2009

Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses

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] - Immune System Diseases [C20]

Product Name: teriflunomide
Product Code: HMR1726D
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

1080

Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden

328

NCT02275741
(ClinicalTrials.gov)

October 2009

22/10/2014

Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Biological: prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal)

Dr. med. Micha Loebermann

NULL

Completed

18 Years

70 Years

All

226

Germany

329

EUCTR2006-003361-14-EE
(EUCTR)

25/09/2009

19/08/2009

Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Product Name: teriflunomide
Product Code: HMR1726D
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

1080

Portugal;Czech Republic;Estonia;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

330

EUCTR2008-002626-11-SE
(EUCTR)

02/07/2009

24/04/2009

Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis

Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSIT

Severe progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Trade Name: Mabthera
Other descriptive name: RITUXIMAB

Dept of Neurology

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

331

EUCTR2008-003706-33-FR
(EUCTR)

02/07/2009

12/03/2009

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

642

Phase 3

Portugal;Germany;Bulgaria;France;Norway;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece

332

EUCTR2008-004954-34-BG
(EUCTR)

28/05/2009

29/05/2009

Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)

Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a

Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

492

333

EUCTR2008-004954-34-GR
(EUCTR)

19/05/2009

06/03/2009

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

334

NCT01075880
(ClinicalTrials.gov)

May 2009

24/2/2010

Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®

Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif

Multiple Sclerosis, Relapsing-Remitting

Drug: Rebif (Interferon beta-1a)

Merck KGaA

Merck spol.s.r.o., Czech Republic

Completed

18 Years

65 Years

Both

300

N/A

Czech Republic

335

EUCTR2008-004954-34-IT
(EUCTR)

08/04/2009

12/03/2009

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 at high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: REBIF *SC 12SIR 12000000UI44MCG
INN or Proposed INN: Interferon beta -1a

MERCK SERONO SA

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

336

EUCTR2008-003706-33-AT
(EUCTR)

02/04/2009

24/11/2008

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece

337

EUCTR2008-003706-33-NO
(EUCTR)

18/03/2009

09/12/2008

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece

338

EUCTR2008-004954-34-LV
(EUCTR)

12/03/2009

27/02/2009

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 S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

492

Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Germany

339

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

340

EUCTR2008-003706-33-PT
(EUCTR)

06/03/2009

17/12/2008

Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta -1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA -1A

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;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

341

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

342

EUCTR2008-003706-33-IT
(EUCTR)

02/03/2009

23/02/2009

Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: CLADRIBINE
INN or Proposed INN: Cladribine
Trade Name: REBIF *SC 12SIR 12000000UI44MCG
INN or Proposed INN: Interferon beta -1a

MERCK SERONO SA

NULL

Not Recruiting

Female: yes
Male: yes

642

Phase 3

Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece

343

EUCTR2008-004954-34-EE
(EUCTR)

13/02/2009

08/01/2009

Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)

Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a

Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

492

344

EUCTR2008-004954-34-PT
(EUCTR)

06/02/2009

05/01/2009

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 S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

492

Phase 3

Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia

345

NCT00836719
(ClinicalTrials.gov)

February 2009

3/2/2009

Safety of Polyphenon E in Multiple Sclerosis Pilot Study

Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis

Multiple Sclerosis

Drug: Polyphenon E

Louisiana State University Health Sciences Center in New Orleans

National Center for Complementary and Integrative Health (NCCIH)

Completed

18 Years

65 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

346

EUCTR2008-003706-33-ES
(EUCTR)

29/01/2009

09/12/2008

A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial

Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS).Sujetos con un primer episodio de desmielinización clínica (Síndrome aislado desde el punto de vista clínico (CIS)) de alto riesgo de conversión a Esclerosis Múltiple (EM).
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2?-deoxy-ß-D-adenosine
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta -1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA -1A

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

642

Phase 3

Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece

347

EUCTR2007-001377-28-PT
(EUCTR)

09/01/2009

25/08/2008

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL

Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

348

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

349

NCT01080027
(ClinicalTrials.gov)

October 2008

2/3/2010

Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)

An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life Settings

Multiple Sclerosis, Relapsing Remitting

Drug: Rebif ® New Formulation

Merck KGaA

Merck A.E., Greece;Merck OY, Finland;Merck B.V., Netherlands;Merck A.B., Sweden;Merck, S.A., Portugal

Completed

18 Years

60 Years

Both

254

N/A

Greece

350

EUCTR2007-001377-28-DE
(EUCTR)

01/09/2008

15/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;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

351

NCT01184833
(ClinicalTrials.gov)

September 2008

18/8/2010

Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis

Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

Drug: Interferon beta -1b (Betaseron, BAY86-5046)

Bayer

NULL

Completed

18 Years

N/A

Both

852

N/A

Poland

352

EUCTR2007-000381-20-NL
(EUCTR)

29/08/2008

01/02/2008

A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). -

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3b

Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece

353

EUCTR2006-003361-14-DK
(EUCTR)

29/08/2008

22/07/2008

Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Product Name: teriflunomide
Product Code: HMR1726D
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

1080

Portugal;Estonia;Czech Republic;Finland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden

354

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

355

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

356

EUCTR2007-001377-28-NL
(EUCTR)

15/07/2008

29/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

357

EUCTR2007-001377-28-AT
(EUCTR)

26/06/2008

27/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

358

EUCTR2007-001377-28-FR
(EUCTR)

11/06/2008

29/02/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

359

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

360

EUCTR2007-000381-20-IT
(EUCTR)

29/05/2008

20/03/2008

VEDI ITALIANO - CLARITY EXTENTION

SCLEROSI MULTIPLA A RICADUTE E REMISSIONI
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: CLADRIBINA
Product Code: NA
INN or Proposed INN: Cladribine

MERCK SERONO SA

NULL

Not Recruiting

Female: yes
Male: yes

1100

Portugal;Estonia;Greece;Finland;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;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

361

EUCTR2007-007394-22-GB
(EUCTR)

22/05/2008

11/04/2008

The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning

Multiple Sclerosis
MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive

Trade Name: Tysabri
Product Name: Tysabri

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

362

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

363

EUCTR2007-000381-20-PT
(EUCTR)

28/04/2008

15/01/2008

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

1100

Phase 3b

Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece

364

NCT01414816
(ClinicalTrials.gov)

April 2008

13/7/2011

Betaferon® Regulatory Post-Marketing Surveillance

Multiple Sclerosis;Clinically Isolated System

Drug: Interferon beta -1b (Betaseron, BAY86-5046)

Bayer

NULL

Completed

12 Years

N/A

Both

355

N/A

Korea, Republic of

365

EUCTR2007-000192-42-IT
(EUCTR)

10/03/2008

31/07/2007

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND

urinary incontinence caused by neurogenic detrusor overactivity (spinal lesion or multiple sclerosis)
MedDRA version: 9.1;Level: LLT;Classification code 10029279;Term: Neurogenic bladder

Trade Name: BOTOX
INN or Proposed INN: Botulinum toxin

ALLERGAN

NULL

Not Recruiting

Female: yes
Male: yes

260

Portugal;United Kingdom;Germany;Netherlands;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

366

EUCTR2006-003361-14-PT
(EUCTR)

07/03/2008

07/01/2008

Multiple Sclerosis study to document the safety of two doses of teriflunomide

Multiple sclerosis
MedDRA version: 18.1;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: HMR1726D
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

1080

Phase 3

Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

367

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

368

NCT00984984
(ClinicalTrials.gov)

March 2008

24/9/2009

Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses

Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses

Multiple Sclerosis, Relapsing-Remitting

Drug: methylprednisolone PO;Drug: methylprednisolone IV

Rennes University Hospital

NULL

Recruiting

18 Years

55 Years

Both

200

Phase 3

France

369

EUCTR2006-003361-14-NL
(EUCTR)

12/02/2008

07/01/2008

Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Product Name: teriflunomide
Product Code: HMR1726D
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

1080

Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Norway;Sweden

370

EUCTR2004-000555-42-GB
(EUCTR)

05/02/2008

03/03/2005

A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses

Multiple sclerosis

Sanofi-aventis US, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3

Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;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

371

EUCTR2007-003226-19-PT
(EUCTR)

01/02/2008

24/10/2007

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

1000

Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

372

EUCTR2007-005414-40-IT
(EUCTR)

21/12/2007

28/11/2007

Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND

Patients with an established and stable Multiple Sclerosis (according to Poser criteria).
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: KEPPRA
INN or Proposed INN: Levetiracetam

AZIENDA SANITARIA N. 3 GENOVESE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

373

EUCTR2007-000381-20-FR
(EUCTR)

14/12/2007

17/10/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)

Merck Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3b

Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece

374

EUCTR2006-002982-38-LT
(EUCTR)

30/11/2007

01/10/2006

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: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

375

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

No.

TrialID

Date_
enrollment

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

NCT01235455
(ClinicalTrials.gov)

August 2007

4/11/2010

Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors

Portuguese BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis (MS) After Conversion to Betaferon by Using Elements of the BetaPlus Program

Relapsing Remitting Multiple Sclerosis (RRMS);Secondary Progressive Multiple Sclerosis (SPMS)

Drug: Interferon beta -1b (Betaseron, BAY86-5046)

Bayer

NULL

Completed

18 Years

N/A

Both

N/A

Portugal

377

EUCTR2006-003361-14-SE
(EUCTR)

24/07/2007

27/06/2007

Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Product Name: teriflunomide
Product Code: HMR1726D
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

1080

Phase 3

Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

378

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

379

EUCTR2004-000555-42-EE
(EUCTR)

06/07/2007

18/04/2007

A randomized, double-blind, placebo-controlled, parallel group design study toevaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing thefrequency of relapses and delaying the accumulation of physical disability insubjects with multiple sclerosis with relapses.

Multiple sclerosis
MedDRA version: 12.0;Level: PT;Classification code 10028245;Term:

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

Not Recruiting

Female: yes
Male: yes

1080

Portugal;Czech Republic;United Kingdom;Denmark;Norway;Estonia;Italy;Sweden

380

EUCTR2006-002982-38-PT
(EUCTR)

29/05/2007

22/02/2007

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 S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;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

381

EUCTR2006-003361-14-IT
(EUCTR)

23/05/2007

07/03/2007

Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND

Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: teriflunomide
Product Code: HMR1726D
Product Name: teriflunomide
Product Code: HMR1726D

sanofi-aventis recherche de veloppement

NULL

Not Recruiting

Female: yes
Male: yes

1080

Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden

382

EUCTR2006-005460-30-IT
(EUCTR)

22/05/2007

27/10/2008

POPART?MUS Prevention of Post Partum Relapses with Progestin and Estradiolin Multiple sclerosis - POPART`MUS

Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: DEMESTRIL SEPTEM
INN or Proposed INN: Estradiol
Trade Name: LUTENYL
INN or Proposed INN: Nomegestrol

OSPEDALI CIVILI DI LIONE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: no

300

Italy

383

EUCTR2004-000555-42-CZ
(EUCTR)

14/05/2007

09/03/2007

Multiple sclerosis
MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis

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

sanofi-aventis U.S Inc

NULL

Not Recruiting

Female: yes
Male: yes

1080

Portugal;United Kingdom;Czech Republic;Denmark;Estonia;Norway;Italy;Sweden

384

EUCTR2006-002982-38-GR
(EUCTR)

08/05/2007

29/12/2006

Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245

Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

385

EUCTR2006-000704-17-BE
(EUCTR)

25/04/2007

06/07/2006

A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302

Relapsing-remitting multiple sclerosis (RRMS)

Product Code: FTY720
INN or Proposed INN: Fingolimod

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1275

Portugal;Hungary;Greece;Spain;Belgium;Austria;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

386

EUCTR2006-000704-17-HU
(EUCTR)

16/04/2007

27/07/2006

Relapsing-remitting multiple sclerosis (RRMS)

Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: Fingolimod

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1275

Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria

387

EUCTR2006-002982-38-DE
(EUCTR)

16/03/2007

10/10/2006

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 S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany

388

EUCTR2006-002982-38-EE
(EUCTR)

15/03/2007

31/10/2006

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;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

389

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

390

EUCTR2006-003361-14-GB
(EUCTR)

23/01/2007

29/09/2006

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]

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3

Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;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

391

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

392

EUCTR2006-002982-38-FR
(EUCTR)

05/01/2007

24/10/2006

Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245

Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a

Serono International SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

393

EUCTR2006-002982-38-DK
(EUCTR)

20/12/2006

30/11/2006

Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245

Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Denmark;Belgium;Estonia;Spain;Greece

394

EUCTR2006-002982-38-FI
(EUCTR)

19/12/2006

19/10/2006

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 S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

395

EUCTR2006-000704-17-GR
(EUCTR)

19/12/2006

11/08/2006

Relapsing-remitting multiple sclerosis (RRMS)

Product Code: FTY720
INN or Proposed INN: Fingolimod
Product Name: Interferon beta -1a
INN or Proposed INN: interferon beta -1a

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1275

Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;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

396

EUCTR2006-003361-14-FI
(EUCTR)

19/12/2006

10/11/2006

Multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Product Name: teriflunomide
Product Code: HMR1726D
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

1080

Phase 3

Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

397

EUCTR2006-002982-38-ES
(EUCTR)

13/12/2006

10/03/2010

Ensayo clínico multicéntrico en Fase III, randomizado, doble-ciego, controlado con placebo, de Rebif New Formulation (44 mcg tres veces por semana y 44 mcg una vez por semana) en pacientes con alto riesgo de conversión a esclerosis múltiple.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 44 microgramos solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A

Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany

398

EUCTR2006-002982-38-AT
(EUCTR)

04/12/2006

29/09/2006

Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245

Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

399

EUCTR2006-002982-38-BE
(EUCTR)

29/11/2006

14/09/2006

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 S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, Germany

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

400

EUCTR2006-000606-23-ES
(EUCTR)

23/11/2006

15/03/2012

?Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase

Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif

Not applicalbe
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: Rebif 22 y 44 mcg
Product Name: Interferon-beta -1a
Other descriptive name: INTERFERON BETA -1A

Merck, S.L.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase -

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

401

EUCTR2006-002982-38-IT
(EUCTR)

09/11/2006

04/12/2006

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 - REFLEX

clinically isolated syndrome suggestive of multiple sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Interferon beta -1a FBS-free/HSA-free, RNF
INN or Proposed INN: Interferon beta -1a

Serono International SA

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

402

EUCTR2006-002982-38-CZ
(EUCTR)

03/11/2006

15/09/2006

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 S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

403

EUCTR2006-000704-17-GB
(EUCTR)

19/10/2006

10/05/2006

Relapsing-remitting multiple sclerosis (RRMS)

Product Code: FTY720
INN or Proposed INN: Fingolimod
Product Name: Interferon beta -1a
INN or Proposed INN: interferon beta -1a
Product Code: FTY720
INN or Proposed INN: Fingolimod

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1275

Phase -

Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria

404

EUCTR2006-000704-17-IT
(EUCTR)

15/09/2006

06/11/2009

A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302

Relapsing-remitting multiple sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10028245

Product Name: fingolimod
Product Code: FTY720D
Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: Interferon beta -1a

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

1275

Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria

405

EUCTR2006-000704-17-AT
(EUCTR)

08/09/2006

12/07/2006

Relapsing-remitting multiple sclerosis (RRMS)

Product Code: FTY720
INN or Proposed INN: Fingolimod

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1275

Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;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

406

EUCTR2004-001286-17-PT
(EUCTR)

08/09/2006

23/03/2006

Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis

Relapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity
MedDRA version: 7.0;Level: PT;Classification code 10028245

Product Name: Mitoxantrone
Product Code: N/A

Fundación Española de Esclerosis Múltiple (FEDEM)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Portugal

407

EUCTR2005-005751-18-GB
(EUCTR)

07/09/2006

17/02/2006

A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study

Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.

Trade Name: Rebif 44
Product Name: Rebif 44
Product Code: Interferon beta 1a
INN or Proposed INN: Interferon beta 1a
Trade Name: Rebif 22
Product Name: Rebif 22
Product Code: Interferon beta 1a
INN or Proposed INN: Interferon beta 1a
Product Name: Betaferon 500mcg
Product Code: Betaferon 500mcg
INN or Proposed INN: Interferon beta 1b

UCL Biomedicine R&D Unit

NULL

Not Recruiting

Female: yes
Male: yes

100

United Kingdom

408

EUCTR2006-000704-17-DE
(EUCTR)

21/08/2006

12/06/2006

Relapsing-remitting multiple sclerosis (RRMS)

Product Code: FTY720
INN or Proposed INN: Fingolimod

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1275

Phase -

Portugal;Hungary;United Kingdom;Germany;Belgium;Spain;Italy;Greece;Austria

409

NCT00288626
(ClinicalTrials.gov)

July 2006

7/2/2006

High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study

A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis

Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone;Drug: Carmustine , etoposide, cytarabine, and melphalan (BEAM);Procedure: Autologous hematopoietic stem cell transplant

National Institute of Allergy and Infectious Diseases (NIAID)

Immune Tolerance Network (ITN)

Completed

18 Years

60 Years

All

Phase 2

United States

410

EUCTR2004-000555-42-PT
(EUCTR)

26/01/2006

04/11/2005

Multiple sclerosis

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

Aventis Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

870

Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;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

411

EUCTR2004-000555-42-DK
(EUCTR)

12/12/2005

23/01/2008

Multiple sclerosis
MedDRA version: 12.0;Level: PT;Classification code 10028245;Term:

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

Sanofi-aventis US, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1080

Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden

412

NCT00127075
(ClinicalTrials.gov)

June 2005

4/8/2005

POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis

Multiple Sclerosis

Drug: nomegestrol acetate;Drug: estradiol;Drug: placebo

Hospices Civils de Lyon

NULL

Active, not recruiting

18 Years

50 Years

Female

300

Phase 3

France

413

NCT00942591
(ClinicalTrials.gov)

May 2005

17/7/2009

Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b

Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis.

Multiple Sclerosis

Drug: Interferon beta 1b;Drug: Atorvastatin

University Hospital Inselspital, Berne

CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel

Completed

18 Years

55 Years

Both

Phase 2

Switzerland

414

NCT01142492
(ClinicalTrials.gov)

January 2005

10/6/2010

A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif®)

Postmarketing Surveillance Study on the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis With Interferon Beta 1a (Rebif®)

Relapsing-Remitting Multiple Sclerosis

Drug: Interferon beta -1a

Merck KGaA

NULL

Completed

N/A

Both

403

N/A

NULL

415

EUCTR2004-000555-42-IT
(EUCTR)

30/12/2004

23/11/2004

A randomized, double-blind, placebo-controlled, parallel-group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO

Multiple sclerosis with relapses
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: TERIFLUNOMIDE
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE

sanofi-aventis Recherche & De`veloppement

NULL

Not Recruiting

Female: yes
Male: yes

870

Portugal;Estonia;Czech Republic;Denmark;Norway;United Kingdom;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

416

EUCTR2004-000555-42-AT
(EUCTR)

02/12/2004

28/10/2004

Multiple sclerosis
MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis

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

Sanofi-Aventis US, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1080

Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;United Kingdom;Italy;Sweden

417

EUCTR2004-000555-42-NO
(EUCTR)

22/11/2004

27/09/2004

Multiple sclerosis

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

Sanofi-aventis US, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1080

Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden

418

EUCTR2004-000555-42-SE
(EUCTR)

17/11/2004

29/09/2004

Multiple sclerosis
MedDRA version: 12.0;Level: PT;Classification code 10028245;Term:

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

Sanofi-aventis US, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1080

Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden

419

EUCTR2004-000663-99-HU
(EUCTR)

08/11/2004

08/09/2004

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

MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.

Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate

Biogen Idec Inc.

Biogen Idec Ltd

Not Recruiting

Female: yes
Male: yes

260

Hungary;Sweden

420

EUCTR2004-000663-99-CZ
(EUCTR)

12/10/2004

22/10/2004

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

Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate

Biogen Idec Inc.

Biogen Idec Ltd

Not Recruiting

Female: yes
Male: yes

260

Hungary;Czech Republic;Sweden

No.

TrialID

Date_
enrollment

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

EUCTR2005-000393-47-IT
(EUCTR)

22/09/2004

05/03/2007

Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study.

Treatment of spasticity in patients with Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: Cannabis Based Medicine Extract (Sativex)

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

NULL

Not Recruiting

Female: yes
Male: yes

Italy

422

EUCTR2004-000663-99-SE
(EUCTR)

10/09/2004

03/08/2004

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

Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate

Biogen Idec Inc.

Biogen Idec Ltd

Not Recruiting

Female: yes
Male: yes

260

Hungary;Sweden

423

EUCTR2004-000073-64-FI
(EUCTR)

03/09/2004

14/07/2004

A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - -

Aaltomainen MS-tauti

Merck & Co., Inc./Suomen MSD Oy

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Finland

424

NCT00315367
(ClinicalTrials.gov)

September 2004

14/4/2006

A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties

A Double-Blind, Crossover Trial of Aricept® in Memory-Impaired Patients With Multiple Sclerosis: A Phase IV Demonstration of Functional MRI (fMRI) as a Surrogate Marker of Brain Activity Associated With Improvement in Memory Function

Relapsing-Remitting Multiple Sclerosis

Drug: Donepezil HCI (drug)

Neurognostics

NULL

Completed

18 Years

65 Years

Both

Phase 4

United States

425

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

No.

TrialID

Date_
enrollment

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

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

427

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

428

JPRN-JapicCTI-050031

06/09/2005

Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)

[Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injury

Intervention name : Baclofen
Dosage And administration of the intervention : Intertheacal injection

DAIICHI SANKYO COMPANY, LIMITED

NULL

BOTH

Phase 4

NULL

429

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

430

EUCTR2011-005249-12-FR
(EUCTR)

17/06/2015

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

Female: yes
Male: yes

165

Phase 3

Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;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

431

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

432

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