13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

  
1143 trials found
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1NCT04880577
(ClinicalTrials.gov)
September 15, 202230/4/2021Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple SclerosisTenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;FatigueDrug: TENOFOVIR ALAFENAMIDE FUMARATE 25 Mg ORAL TABLET [VEMLIDY];Drug: PlaceboHarvard Medical SchoolGilead SciencesNot yet recruiting18 YearsN/AAll60Phase 2NULL
2NCT05266469
(ClinicalTrials.gov)
May 1, 202223/2/2022Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the GulfExploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf RegionRelapsing Multiple SclerosisOther: Ofatumumab;Other: OcrelizumabNovartis PharmaceuticalsNULLNot yet recruiting18 Years100 YearsAll240NULL
3NCT05285891
(ClinicalTrials.gov)
April 30, 20228/3/2022Ocrelizumab Discontinuation in Relapsing Multiple SclerosisRandomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)Multiple SclerosisBiological: Ocrelizumab;Drug: Placebo for OcrelizumabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence (ACE)Not yet recruiting18 Years55 YearsAll175Phase 4NULL
4NCT05090033
(ClinicalTrials.gov)
April 30, 202222/9/2021Characterizing the Use of Ofatumumab in a Real World SettingSecondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS Patients Using MSGo, With a Non-interventional Primary Use of Data Sub-study Comparing Patient Reported Outcomes Relative to Clinical Outcomes (EAFToS)Relapsing Multiple SclerosisOther: ofatumumabNovartis PharmaceuticalsNULLNot yet recruiting18 YearsN/AAll3500NULL
5NCT05284175
(ClinicalTrials.gov)
April 20229/3/2022A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum DisorderA Prospective, Self-controlled Study to Explore Efficacy and Safety of Orelabrutinib in AQP4-IgG Positive Neuromyelitis Optica Spectrum DisorderNeuromyelitis Optica Spectrum DisorderDrug: OrelabrutinibPeking Union Medical College HospitalBeijing InnoCare Pharma Tech Co., Ltd.;GCP ClinPlus Co., Ltd.Not yet recruiting18 Years75 YearsAll23N/AChina
6NCT05232825
(ClinicalTrials.gov)
March 31, 202227/1/2022A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple SclerosisA Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple SclerosisRelapsing Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Ocrelizumab IV;Drug: Ocrelizumab SC;Drug: Methylprednisolone IV;Drug: Diphenhydramine IV;Drug: Dexamethasone given orally;Drug: Desloratadine given orallyHoffmann-La RocheNULLNot yet recruiting18 Years65 YearsAll232Phase 3United States;Brazil;Canada;Czechia;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine
7NCT05285904
(ClinicalTrials.gov)
March 30, 20228/3/2022Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational StudyKesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)Multiple SclerosisOther: OfatumumabNovartis PharmaceuticalsNULLNot yet recruiting18 Years99 YearsAll149NULL
8NCT05265728
(ClinicalTrials.gov)
March 25, 202223/2/2022A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple SclerosisA Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of AdministrationMultiple Sclerosis, Relapsing-RemittingDrug: NatalizumabBiogenNULLNot yet recruiting18 Years65 YearsAll20Phase 3NULL
9NCT05062083
(ClinicalTrials.gov)
March 24, 202229/9/2021PET Imaging of Cyclooxygenase-2 in Multiple SclerosisPET Imaging of Cyclooxygenase-2 in Multiple SclerosisMultiple SclerosisDrug: 11C-MCINational Institute of Mental Health (NIMH)University of MarylandRecruiting18 Years80 YearsAll16Phase 2United States
10NCT05269004
(ClinicalTrials.gov)
March 15, 202211/2/2022A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple SclerosisA Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple SclerosisMultiple SclerosisDrug: OcrelizumabHoffmann-La RocheNULLNot yet recruiting18 YearsN/AAll1300Phase 3NULL
11NCT05090371
(ClinicalTrials.gov)
March 2, 202212/10/2021A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) ElevationA Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)Relapsing-Remitting Multiple SclerosisDrug: Ofatumumab;Drug: Disease modifying treatment (DMT)Novartis PharmaceuticalsNULLRecruiting18 Years50 YearsAll150Phase 4United States
12NCT05007483
(ClinicalTrials.gov)
March 1, 20229/8/2021Efficacy of Diet on Quality of Life in Multiple SclerosisEfficacy of Diet on Quality of Life in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDietary Supplement: BodyBio Balance Oil;Dietary Supplement: Kirunal Fish Oil;Dietary Supplement: BodyBio PC;Behavioral: Modified Paleolithic Elimination diet;Behavioral: Time Restricted Olive Oil Based (TROO) Ketogenic Diet;Behavioral: Dietary Guidelines for Americans DietTerry L. WahlsNULLNot yet recruiting18 Years70 YearsAll156N/AUnited States
13NCT05269628
(ClinicalTrials.gov)
March 202213/2/2022Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain PhenotypeMechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain PhenotypeMultiple Sclerosis;Sleep;PainDrug: Cannabidiol (CBD);Drug: Tetrahydrocannabinol (THC);Drug: Placebo CBD;Drug: Placebo THCTiffany J. Braley, MD, MSNational Center for Complementary and Integrative Health (NCCIH)Not yet recruiting18 Years65 YearsAll166Phase 2United States
14NCT05208840
(ClinicalTrials.gov)
February 28, 202212/1/2022A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple SclerosisOpen-Label Multicenter Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple SclerosisMultiple SclerosisDrug: OcrelizumabHoffmann-La RocheNULLRecruiting18 Years65 YearsAll50Phase 4Russian Federation
15NCT05199688
(ClinicalTrials.gov)
February 28, 20223/12/2021A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica Spectrum Disorder;NMOSDDrug: SatralizumabHoffmann-La RocheNULLNot yet recruiting2 Years11 YearsAll8Phase 3United States;Argentina;Italy;Mexico;Ukraine
16NCT05145361
(ClinicalTrials.gov)
February 28, 202221/11/2021Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)NMO Spectrum DisorderDrug: B001 injection;Biological: PlaceboShanghai Pharmaceuticals Holding Co., LtdNULLNot yet recruiting18 Years70 YearsAll45Early Phase 1China
17NCT04877457
(ClinicalTrials.gov)
February 15, 202230/4/2021Ocrelizuamb for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Ocrelizumab in Patients With Radiologically Isolated SyndromeRadiologically Isolated Syndrome;Multiple SclerosisDrug: Ocrelizumab;Other: PlaceboYale UniversityGenentech, Inc.Recruiting18 Years40 YearsAll100Phase 4United States
18NCT05123703
(ClinicalTrials.gov)
February 4, 202216/11/2021A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple SclerosisA Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: Ocrelizumab;Other: Ocrelizumab Placebo;Drug: Fingolimod;Other: Fingolimod PlaceboHoffmann-La RochePPDRecruiting10 Years17 YearsAll233Phase 3United States;Argentina;Spain;Ukraine;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Denmark;Germany;Greece;Hungary;Italy;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Switzerland;Turkey;United Kingdom
19NCT05003388
(ClinicalTrials.gov)
February 20226/8/2021Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for MSSafety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Multiple SclerosisMultiple SclerosisBiological: AlloRxThe Foundation for Orthopaedics and Regenerative MedicineNULLRecruitingN/AN/AAll15Phase 1Antigua and Barbuda
20NCT05171972
(ClinicalTrials.gov)
January 29, 202210/12/2021Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab TreatmentAssessing Reduced Oligodendrocyte-specific Cytotoxicity of Peripheral Blood Leukocytes in Patients With Multiple Sclerosis Following Treatment With OfatumumabRelapsing Remitting Multiple SclerosisDrug: OfatumumabUniversity of Southern CaliforniaNovartis PharmaceuticalsRecruiting18 Years65 YearsAll40United States
21NCT05119569
(ClinicalTrials.gov)
January 28, 202229/10/2021A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: placeboHoffmann-La RocheNULLNot yet recruiting18 Years55 YearsAll102Phase 2NULL
22NCT05084638
(ClinicalTrials.gov)
January 25, 20227/10/2021Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.Relapse Remitting Multiple SclerosisDrug: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years35 YearsAll168Phase 4United States
23NCT04764383
(ClinicalTrials.gov)
January 1, 202218/2/2021Histaminergic Basis of Fatigue in Multiple SclerosisHistaminergic Basis of Fatigue in Multiple SclerosisMultiple SclerosisDrug: L-Histidine;Drug: Placebo;Drug: LodosynUniversity of MiamiNULLWithdrawn18 Years60 YearsAll0Phase 2United States
24NCT05177718
(ClinicalTrials.gov)
January 1, 202213/12/2021Natalizumab and Chronic InflammationAssessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin IntegrityMultiple SclerosisDrug: Natalizumab 300 MG in 15 ML InjectionVanderbilt University Medical CenterBiogenRecruiting18 Years65 YearsAll36Phase 4United States
25NCT05165238
(ClinicalTrials.gov)
January 202217/12/2021Impact Program for Multiple SclerosisImpact of a Four-Week Coaching Program on Dietary Habits in Adults With Multiple SclerosisMultiple SclerosisBehavioral: Impact of four week coaching program on dietary habitsUniversity of Alabama at BirminghamNULLNot yet recruiting18 Years65 YearsAll50N/ANULL
26NCT05147532
(ClinicalTrials.gov)
January 202215/10/2021Remyelination in Multiple Sclerosis: a PET-MR Longitudinal Study Investigating Individual Profiles of Myelin Repair and the Contribution of NeuroinflammationRemyelination in Multiple Sclerosis: a PET-MR Longitudinal Study Investigating Individual Profiles of Myelin Repair and the Contribution of NeuroinflammationMultiple Sclerosis;Inflammatory DiseaseProcedure: PET-MRI with [18F]-Florbetaben and PET-MRI with [18F]-DPA-714Assistance Publique - Hôpitaux de ParisNULLNot yet recruiting18 Years55 YearsAll80N/ANULL
27NCT05201638
(ClinicalTrials.gov)
January 202213/12/2021Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple SclerosisA Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-2)Multiple Sclerosis, Relapsing-RemittingDrug: IMU-838 tablets;Drug: Placebo matching IMU-838 tabletsImmunic AGNULLNot yet recruiting18 Years55 YearsAll1050Phase 3NULL
28NCT03807973
(ClinicalTrials.gov)
December 30, 202114/1/2019Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.Fibromyalgia;Chronic Fatigue Syndrome;Multiple Sclerosis;HealthyDrug: [Zr-89]Oxine-labeled leukocytes PET/MRUniversity of Alabama at BirminghamNULLNot yet recruiting18 Years65 YearsAll120Phase 1NULL
29NCT05147220
(ClinicalTrials.gov)
December 16, 202124/11/2021Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple SclerosisA Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label RemibrutinibRelapsing Multiple SclerosisDrug: Remibrutinib;Drug: TeriflunomideNovartis PharmaceuticalsNULLRecruiting18 Years55 YearsAll800Phase 3United States
30NCT05092191
(ClinicalTrials.gov)
December 15, 20211/9/2021Cannabis as a Complementary Treatment in Multiple SclerosisEfficacy of Cannabinoids to the Current Standard Treatments on Symptom Relief in Persons With Multiple Sclerosis: Randomized Controlled TrialMultiple SclerosisDrug: Cannabis oil vs placeboCentre hospitalier de l'Université de Montréal (CHUM)Canadian Institutes of Health Research (CIHR);Multiple Sclerosis Society of CanadaNot yet recruiting21 YearsN/AAll250Phase 3NULL
31NCT05156281
(ClinicalTrials.gov)
December 13, 20211/12/2021Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label RemibrutinibRelapsing Multiple SclerosisDrug: Remibrutinib;Drug: TeriflunomideNovartis PharmaceuticalsNULLRecruiting18 Years55 YearsAll800Phase 3United States
32JPRN-jRCT2051210115
09/12/202129/10/2021A Study of Diroximel Fumarate (DRF) in Adult Participants from the Asia-Pacific Region with Relapsing Forms of Multiple Sclerosis (RMS)An Open-Label, Single-Arm, Multicenter, Phase 3 Study to Evaluate the Safety and Tolerability, and Pharmacokinetics of Diroximel Fumarate (BIIB098) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis Relapsing Forms of Multiple Sclerosis (RMS)Research Name: BIIB098 (also known as ALK8700)
Generic Name: Diroximel Fumarate (DRF)
Trade Name: Vumerity
Participants will initiate treatment with DRF 231 mg twice daily on Day 1 through Day 7, followed by 462 mg twice daily from Day 8 onwards.
Hanna Jerome ThomasNULLRecruiting>= 18age old<= 65age oldBoth100Phase 3China;Japan
33NCT04787497
(ClinicalTrials.gov)
December 20211/3/2021The Effect of Extra Virgin Olive Oil in People With Multiple SclerosisThe Neuropsychological Effects of Extra-Virgin Olive Oil in People With Multiple SclerosisMultiple SclerosisDietary Supplement: High Phenolic Extra Virgin Olive OilUniversity of CyprusWorld Olive Center for Health;Ellis-Farm, Eliama Daily ValueNot yet recruiting18 Years65 YearsAll100N/ANULL
34NCT05116540
(ClinicalTrials.gov)
November 24, 202127/10/2021Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple SclerosisA Randomized, Double-Blind, Single-Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Multiple SclerosisMultiple SclerosisBiological: HB-adMSCs;Drug: PlaceboHope Biosciences Stem Cell Research FoundationNULLRecruiting18 Years75 YearsAll24Phase 2United States
35NCT04895202
(ClinicalTrials.gov)
November 19, 202117/5/2021Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional StudySwiss Study of the Impact of Mayzent (Siponimod) on Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional StudySecondary Progressive Multiple Sclerosis With Inflammatory Disease ActivityOther: SiponimodNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll60Switzerland
36NCT04574024
(ClinicalTrials.gov)
November 16, 202121/9/2020HFP (High-Fiber Supplement) in MS (Multiple Sclerosis)Effect of High-fiber Supplement in Multiple SclerosisMultiple SclerosisDrug: NBT-NM108 (60 g/day);Other: NBT-NM108 (0 g/day)Suhayl Dhib-Jalbut, MDNULLEnrolling by invitation21 Years55 YearsAll50Phase 1/Phase 2United States
37NCT04943289
(ClinicalTrials.gov)
November 15, 202121/6/2021Intrathecal Administration of DUOC-01 in Adults With Primary Progressive Multiple SclerosisPhase IA Trial of Intrathecal Administration of Human Umbilical Cord Blood-Derived Cell Therapy (DUOC-01) in Adults With Primary Progressive Multiple Sclerosis (PPMS)Primary Progressive Multiple SclerosisBiological: DUOC-01Joanne Kurtzberg, MDNULLNot yet recruiting18 Years65 YearsAll20Phase 1United States
38NCT05131984
(ClinicalTrials.gov)
November 15, 202110/11/2021Ocrelizumab Access by Socio-Economic StatusOcrelizumab Treatment Access and Outcomes by Gender, Race, and Socio-economic Status in Multiple Sclerosis Patients: Real World InvestigationMultiple SclerosisDrug: OcrelizumabBrigham and Women's HospitalGenentech, Inc.;Boston Medical CenterNot yet recruiting18 YearsN/AAll600United States
39NCT05131971
(ClinicalTrials.gov)
November 1, 202127/10/2021A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy ParticipantsA Randomised, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3888130B in Healthy Participants Aged 18-55 InclusiveMultiple SclerosisDrug: GSK3888130B;Drug: PlaceboGlaxoSmithKlineNULLRecruiting18 Years55 YearsAll70Phase 1United Kingdom
40NCT05122559
(ClinicalTrials.gov)
November 20218/11/2021Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple SclerosisRandomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple SclerosisMultiple Sclerosis;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Secondary ProgressiveDrug: N-acetyl cysteine;Drug: PlaceboEmmanuelle WaubantUnited States Department of DefenseNot yet recruiting40 Years70 YearsAll98Phase 2NULL
41NCT05134441
(ClinicalTrials.gov)
November 202130/9/2021Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple SclerosisA Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)Multiple SclerosisDrug: IMU-838 tablets;Drug: Placebo matching IMU-838 tabletsImmunic AGNULLNot yet recruiting18 Years55 YearsAll1050Phase 3NULL
42NCT05154734
(ClinicalTrials.gov)
October 30, 20217/12/2021Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum DisordersEfficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum DisordersNMO Spectrum DisorderDrug: BelimumabTianjin Medical University General HospitalNULLRecruiting18 YearsN/AAll12Phase 1/Phase 2China
43NCT05028634
(ClinicalTrials.gov)
October 27, 202125/8/2021Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-ß or No Disease Modifying TherapyA Phase 3b, Multicenter, Open-Label Study to Evaluate the Immune Response to, and the Safety of, Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Oral Ozanimod Compared to Non-Pegylated Interferon (IFN)-ß or No Disease Modifying TherapyMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingBiological: Tetanus, diphtheria, and acellular pertussis vaccine;Biological: Pneumococcal polysaccharide vaccine;Biological: Seasonal influenza vaccineCelgeneNULLRecruiting18 Years55 YearsAll60Phase 3United States;Germany
44NCT05064436
(ClinicalTrials.gov)
October 20, 202122/9/2021A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple SclerosisA Phase 1, Open-label, Multi-part Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution, and CNS Signal of the Positron Emission Tomography Ligand 11C-BMS-986196 in Healthy Participants After Intravenous Administration and to Evaluate the Safety, Tolerability, Kinetics, and CNS Signal Repeatability of 11C-BMS-986196 After Repeat Intravenous Administration in Participants With Multiple SclerosisMultiple Sclerosis (MS)Drug: 11C-BMS-986196Bristol-Myers SquibbNULLNot yet recruiting18 Years55 YearsAll14Phase 1United States;United Kingdom
45NCT04926818
(ClinicalTrials.gov)
October 5, 202114/6/2021Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple SclerosisA 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label ExtensionMultiple Sclerosis (MS)Drug: Fingolimod;Drug: Ofatumumab;Drug: Siponimod;Other: Fingolimod placebo;Other: Siponimod placebo;Other: Ofatumumab placeboNovartis PharmaceuticalsNULLRecruiting10 Years17 YearsAll180Phase 3United States;Australia;Austria;Belgium;France;Germany;India;Latvia;Mexico;Poland;Portugal;Russian Federation;Slovakia;Spain;Turkey
46NCT04767698
(ClinicalTrials.gov)
October 1, 202118/2/2021Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple SclerosisAddition of Belimumab to B-cell Depletion to Produce Prolonged Remission of Relapsing-remitting Multiple Sclerosis Disease ActivityMultiple SclerosisDrug: Belimumab;Drug: Short-course Ocrelizumab;Drug: Continued OcrelizumabJohns Hopkins UniversityGlaxoSmithKlineRecruiting18 YearsN/AAll40Phase 2United States
47NCT04540861
(ClinicalTrials.gov)
October 1, 202131/8/2020Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active DiseaseManaged Access Program (MAP) to Provide Access to Siponimod Treatment for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With no Satisfactory Alternative TreatmentMultiple SclerosisDrug: SiponimodNovartis PharmaceuticalsNULLAvailable18 YearsN/AAllNULL
48NCT05046535
(ClinicalTrials.gov)
October 20215/9/2021The Effect of Cigarette Smoke on Sleep Quality and Physical Activity in People With Multiple SclerosisThe Effect of Cigarette Smoke on Sleep Quality and Physical Activity in People With Multiple SclerosisMultiple SclerosisBehavioral: Sleep quality and physical activity;Genetic: Nicotine dependence;Diagnostic Test: Nicotine and cotinine serum levels;Behavioral: SmokingUniversity of JordanNULLNot yet recruiting18 YearsN/AAll80NULL
49NCT05029609
(ClinicalTrials.gov)
October 202127/8/2021Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MSA Phase 1b, Double-Blind, Randomized, Placebo Controlled, Multiple Ascending Dose Study of the Safety, Tolerability and Immune Effects of the Intranasal Anti-CD3 Monoclonal Antibody Foralumab in Primary and Secondary Progressive MSPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Multiple SclerosisDrug: Intranasal Foralumab Solution;Drug: PlaceboTiziana Life Sciences, PLCNULLNot yet recruiting25 Years70 YearsAll55Phase 1NULL
50NCT04874597
(ClinicalTrials.gov)
October 202114/4/2021Investigation of the Effect of Ocrelizumab on Peripheral Lymphocyte Immunophenotypes With Suppressive Capacity in MSThe Effect of Ocrelizumab on the Peripheral Lymphocyte Immunophenotypes With Suppressive Capacity in Patients With Multiple Sclerosis Previously Treated With Disease Modifying Therapy - A Prospective Exploratory Observational StudyMultiple SclerosisDrug: OcrelizumabDr Recai TurkogluHealth Sciences University Istanbul Haydarpasa Numune Training and Research HospitalNot yet recruiting18 YearsN/AAll20Turkey
51NCT05081271
(ClinicalTrials.gov)
October 202114/10/2021COVID-19 Booster Vaccination in Persons With Multiple SclerosisCOVID-19 Booster Vaccination in Persons With Multiple SclerosisPWMS Who Have Completed Vaccination Against COVID-19 and Test Negative for COVID-19 Spike Protein Antibodies Using a Commercial AssayBiological: Homologous booster;Biological: Heterologous boosterGriffin HospitalYale-Griffin Prevention Research CenterNot yet recruiting18 YearsN/AAll60N/ANULL
52NCT05054140
(ClinicalTrials.gov)
September 30, 20212/9/2021Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple SclerosisMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple SclerosisMultiple SclerosisDrug: IMU-838;Drug: Placebo matching IMU-838Immunic AGNULLRecruiting18 Years65 YearsAll450Phase 2United States;Bulgaria;Poland;Ukraine
53NCT04798651
(ClinicalTrials.gov)
September 30, 202111/3/2021Pathogenicity of B and CD4 T Cell Subsets in Multiple SclerosisPathogenicity of B and CD4 T Cell Subsets in Multiple SclerosisMultiple Sclerosis;Clinically Isolated SyndromeBiological: blood sample;Biological: cerebro-spinal fluidUniversity Hospital, BordeauxUniversity of BordeauxRecruiting18 YearsN/AAll150N/AFrance
54NCT04990219
(ClinicalTrials.gov)
September 27, 202129/7/2021A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple SclerosisInterventional, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Phase 1 B Study Investigating the Effects of Lu AG06466 for the Treatment of Spasticity in Patients With Multiple SclerosisMultiple SclerosisDrug: Lu AG06466;Drug: PlaceboH. Lundbeck A/SNULLRecruiting18 Years65 YearsAll78Phase 1United States
55NCT04925557
(ClinicalTrials.gov)
September 27, 202124/5/2021Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple SclerosisOpen-label, Single-blind, Observational, Comparative, Prospective, 36-month, Longitudinal, Controlled Study to Assess Efficacy of Siponimod (Mayzent®) on Microglia in Patients With Active Secondary Progressive Forms of Multiple SclerosisSecondary-progressive Multiple SclerosisDrug: Mayzent;Drug: OcrevusRobert Zivadinov, MD, PhDNULLRecruiting18 Years60 YearsAll60Phase 4United States
56NCT05013463
(ClinicalTrials.gov)
September 1, 202116/8/2021Hydroxychloroquine and Indapamide in SPMSOpen-label, Single-center, Single-arm Futility Trial Evaluating the Combination of Oral Hydroxychloroquine 200mg BID and Indapamide 2.5mg OD for Reducing Progression of Disability in People With Secondary Progressive Multiple Sclerosis (SPMS)Multiple Sclerosis, Secondary ProgressiveDrug: Hydroxychloroquine and IndapamideUniversity of CalgaryNULLNot yet recruiting18 Years60 YearsAll35Phase 2NULL
57NCT04941781
(ClinicalTrials.gov)
September 1, 202118/6/2021PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy VolunteersA Phase 1, Open-label Study of PIPE-307 to Determine Muscarinic Type I Receptor (M1AChR) Occupancy Parameters by [11C] PIPE-307 PET Imaging in Healthy VolunteersMultiple SclerosisDrug: PIPE-307Pipeline Therapeutics, Inc.NULLCompleted25 Years65 YearsAll6Phase 1United Kingdom
58NCT04909502
(ClinicalTrials.gov)
September 202114/5/2021Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple SclerosisA Phase II, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101Relapsing Forms of Multiple SclerosisDrug: EHP-101 25 mg OD;Drug: EHP-101 25 mg BID;Drug: EHP-101 50 mg OD;Drug: EHP-101 50 mg BIDEmerald Health PharmaceuticalsNULLNot yet recruiting18 Years55 YearsAll50Phase 2NULL
59NCT04885894
(ClinicalTrials.gov)
September 202111/5/2021An Examination of Cognitive Fatigue Using Functional NeuroimagingAn Examination of Cognitive Fatigue Using Functional NeuroimagingMultiple Sclerosis, Relapsing-RemittingDrug: ZeposiaKessler FoundationCelgene;Hackensack Meridian Health;St. Barnabas Medical CenterNot yet recruiting18 Years64 YearsAll60United States
60NCT04540770
(ClinicalTrials.gov)
August 31, 202125/8/2020A Phase 1 Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HuL001 in Healthy Volunteers and Multiple Sclerosis SubjectsA Phase 1 Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HuL001 in Healthy Volunteers and Multiple Sclerosis SubjectsMultiple SclerosisDrug: HuL001HuniLife Biotechnology, Inc.NULLRecruiting18 Years55 YearsAll24Phase 1Taiwan
61NCT04956744
(ClinicalTrials.gov)
August 31, 202122/6/2021A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple SclerosisA Phase 1, Dose-Escalating, Open-label Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Single Dose of IV IMS001 in Subjects With Multiple Sclerosis and Treatment Failure to Prior Disease Modifying Treatments (DMTs)Multiple SclerosisBiological: IMS001ImStem BiotechnologyRho, Inc.Recruiting18 Years65 YearsAll30Phase 1United States
62NCT04971005
(ClinicalTrials.gov)
August 27, 202112/8/2020Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled TrialA Randomised Controlled Trial to Compare Ocrelizumab or Alemtuzumab With Autologous Hematopoietic Stem Cell Transplantation (aHSCT) in High Inflammatory Multiple Sclerosis (COAST)Relapsing-Remitting Multiple SclerosisDrug: Autologous Hematopoietic Stem Cell Transplantation;Drug: Ocrelizumab;Drug: AlemtuzumabUniversitätsklinikum Hamburg-EppendorfNeovii Biotech;Clinical Trial Center North (CTC North GmbH & Co. KG)Recruiting18 Years55 YearsAll50Phase 2Germany
63NCT05049161
(ClinicalTrials.gov)
August 27, 202131/8/2021A Long-term Extension of Study GNC-401A Long-term Extension of Study GNC-401 With Temelimab in Patients With Relapsing Forms of Multiple Sclerosis (RMS) Under Treatment With RituximabMultiple SclerosisDrug: Temelimab 18 mg/kg;Drug: Temelimab 36mg/kg;Drug: Temelimab 54 mg/kgGeNeuro Innovation SASNULLRecruiting18 Years55 YearsAll40Phase 2Sweden
64NCT05000216
(ClinicalTrials.gov)
August 13, 20216/8/2021COVID-19 Booster Vaccine in Autoimmune Disease Non-RespondersBooster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)Rheumatoid Arthritis;Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis;Systemic Sclerosis (SSc)Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: IS (MMF or MPA);Drug: IS (MTX);Biological: IS (B cell depletion therapy)National Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Recruiting18 YearsN/AAll600Phase 2United States
65NCT04749667
(ClinicalTrials.gov)
August 9, 202120/1/2021Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple SclerosisStudy of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple SclerosisMultiple Sclerosis;Progressive Multiple SclerosisOther: MSCs;Drug: SalineHaukeland University HospitalUniversity of Bergen;University Hospital Ulm;University Hospital, Akershus;St. Olavs Hospital;University Hospital of North NorwayRecruiting18 Years55 YearsAll18Phase 1/Phase 2Norway
66NCT04982991
(ClinicalTrials.gov)
August 5, 202120/7/2021A Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants.A Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants.Multiple Sclerosis Healthy SubjectsDrug: RIPK1 inhibitorSanofiNULLCompleted20 Years55 YearsAll14Phase 1United Kingdom
67NCT04634994
(ClinicalTrials.gov)
August 20219/11/2020Novel Assessment of Synaptic Density in Progressive MSNovel Assessment of Synaptic Density in Progressive MSPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Relapsing Multiple Sclerosis;Multiple SclerosisDrug: [F-18]SDM-8Brigham and Women's HospitalMassachusetts General HospitalRecruiting18 Years60 YearsAll30Early Phase 1United States
68NCT04815967
(ClinicalTrials.gov)
July 30, 202111/2/2021Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb SpasticityPhase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC in Treatment of Adult Upper Limb Spasticity and Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOCSpasticity;Cerebrovascular Accident;Multiple Sclerosis;Traumatic Brain Injury;Cervical Spinal Cord Injury;Cerebral PalsyDrug: rimabotulinumtoxinB;Drug: PlaceboSupernus Pharmaceuticals, Inc.NULLNot yet recruiting18 Years80 YearsAll272Phase 2/Phase 3NULL
69NCT04788615
(ClinicalTrials.gov)
July 23, 20218/3/2021Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMSOpen-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMSMultiple SclerosisDrug: Ofatumumab;Drug: First line DMTNovartis PharmaceuticalsNULLRecruiting18 Years45 YearsAll236Phase 3France;Germany;Spain;United Kingdom
70NCT04984278
(ClinicalTrials.gov)
July 202114/7/2021Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple SclerosisA 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 SclerosisSpasticity With Multiple SclerosisDrug: Nabiximols;Drug: PlaceboGW Pharmaceuticals Ltd.NULLNot yet recruiting18 YearsN/AAll190Phase 3NULL
71NCT04940065
(ClinicalTrials.gov)
June 30, 202122/6/2021Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg PenSpecial Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen (Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis)Relapsing-remitting Multiple Sclerosis;Active Secondary Progressive Multiple SclerosisOther: KesimptaNovartis PharmaceuticalsNULLRecruitingN/A99 YearsAll330Japan
72NCT04925778
(ClinicalTrials.gov)
June 30, 20218/6/2021Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl FumarateAn Open-label, Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® (Monomethyl Fumarate) From Dimethyl Fumarate (PERSIST)Relapsing Remitting Multiple SclerosisDrug: monomethyl fumarateBanner Life Sciences LLCNULLWithdrawn18 YearsN/AAll0NULL
73NCT04079088
(ClinicalTrials.gov)
June 30, 20213/9/2019Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Placebo;Drug: BIIB061;Biological: Interferon-beta1;Drug: Glatiramer acetateBiogenNULLNot yet recruiting18 Years55 YearsAll300Phase 2NULL
74NCT04695080
(ClinicalTrials.gov)
June 25, 20216/11/2020ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple SclerosisChariotMS - A National (UK) Phase IIb, Multi-centre, Randomised, Double-blind, Placebo Controlled (1:1) Efficacy Trial With Cost-utility Analysis of Cladribine Tablets (3.5mg/kg Over Two Years) in People With Advanced Multiple Sclerosis. Is Cladribine Superior to Placebo in Protecting Upper Limb Function?Advanced Multiple Sclerosis;Progressive Multiple SclerosisDrug: Cladribine (MAVENCLAD®);Drug: PlaceboQueen Mary University of LondonBarts & The London NHS Trust;University Hospital Plymouth NHS Trust;University of Edinburgh;The Leeds Teaching Hospitals NHS Trust;St George's University Hospitals NHS Foundation Trust;University Hospital Birmingham NHS Foundation Trust;Bedfordshire Hospitals NHS Foundation Trust;Northern Care Alliance NHS Foundation Trust;Walton Centre NHS Foundation Trust;Sheffield Teaching Hospitals NHS Foundation Trust;Belfast Health and Social Care Trust;NHS Lothian;NHS Lanarkshire;Barking, Havering and Redbridge University Hospitals NHS Trust;Royal Free London NHS Trust;Swansea Bay University Health Board;NHS Greater Glasgow and Clyde;Nottingham University Hospitals NHS TrustRecruiting18 YearsN/AAll200Phase 2/Phase 3United Kingdom
75NCT04777539
(ClinicalTrials.gov)
June 17, 202123/2/2021Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple SclerosisAssessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple SclerosisMultiple Sclerosis (MS)Other: At-home natalizumab treated MS patientNantes University HospitalRennes University HospitalRecruiting18 YearsN/AAll315France
76NCT04878211
(ClinicalTrials.gov)
June 10, 20213/5/2021A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With OfatumumabAn Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg SubcutaneouslyRelapsing Multiple Sclerosis (RMS)Drug: Ofatumumab;Biological: mRNA COVID-19 vaccine;Drug: interferon or glatiramer acetateNovartis PharmaceuticalsNULLRecruiting18 Years55 YearsAll66Phase 4United States
77NCT04879628
(ClinicalTrials.gov)
June 7, 20216/5/2021Proof-of-concept Study for SAR441344 in Relapsing Multiple SclerosisA Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple SclerosisMultiple SclerosisDrug: SAR441344 IV;Drug: placebo IV;Drug: SAR441344 SC;Drug: placebo SC;Drug: MRI contrast-enhancing preparationsSanofiNULLRecruiting18 Years55 YearsAll120Phase 2United States;Bulgaria;Canada;Czechia;France;Germany;Spain;Turkey;Ukraine
78NCT04625153
(ClinicalTrials.gov)
June 2, 20216/11/2020RC18 in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II TrialRC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II TrialMultiple Sclerosis, Relapsing-RemittingBiological: RC18 160mg;Biological: RC18 240mgRemeGen Co., Ltd.NULLRecruiting18 Years55 YearsAll18Phase 2China
79NCT04819360
(ClinicalTrials.gov)
June 1, 202113/12/2020Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple SclerosisInjections of Botulinum Toxin A or Anticholinergic Treatment as First Line Therapy to Treat Neurogenic Overactive Bladder in Patients With Multiple SclerosisUrinary Bladder, Neurogenic;Multiple SclerosisDrug: VESIcare 10Mg Tablet;Drug: Botox 100 UNT InjectionBrigitte SchürchCentre Hospitalier Universitaire VaudoisRecruiting18 Years75 YearsAll46Phase 4Switzerland
80NCT04869358
(ClinicalTrials.gov)
May 27, 202129/4/2021Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With OfatumumabTracking the Immune Response to SARS-CoV-2 modRNA Vaccines in an Open-label Multicenter Study in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab s.c. (KYRIOS)Multiple SclerosisDrug: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years100 YearsAll40Phase 4Germany
81NCT04979650
(ClinicalTrials.gov)
May 22, 20212/7/2021Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple SclerosisCorticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023Multiple Sclerosis, Relapsing-Remitting;Magnetic Resonance Imaging;MethylprednisoloneDrug: Methylprednisolone succinate;Drug: Normal salineMazandaran University of Medical SciencesNULLEnrolling by invitation18 Years55 YearsAll104Phase 2Iran, Islamic Republic of
82NCT04847596
(ClinicalTrials.gov)
May 21, 202114/4/2021A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With OfatumumabAn Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg SubcutaneouslyRelapsing Multiple SclerosisOther: Ofatumumab;Other: Covid-19 vaccineNovartis PharmaceuticalsNULLRecruiting18 Years55 YearsAll22United States;Puerto Rico
83EUCTR2020-003995-42-IT
(EUCTR)
13/05/202104/06/2021Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 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: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
Product Name: Cladribine tablets
Product Code: [Not Applicable]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 4Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany;Italy
84NCT04676555
(ClinicalTrials.gov)
May 11, 202116/12/2020Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple SclerosisTime and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple SclerosisRelapsing Forms of Multiple SclerosisDrug: Ocrelizumab;Drug: OfatumumabNovartis PharmaceuticalsNULLTerminated18 Years100 YearsAll2United States;Australia;United Kingdom
85NCT04964700
(ClinicalTrials.gov)
May 6, 202127/5/2021Analysis of MS Patients Who Have Had Greater Than 60 Infusions of NatalizumabAnalysis of Multiple Sclerosis Patients Who Have Had Greater Than 60 Infusions of Natalizumab: Safety and EfficacyMultiple SclerosisDrug: NatalizumabMultiple Sclerosis Center of Northeastern New YorkNULLActive, not recruiting18 YearsN/AAll60United States
86NCT04448977
(ClinicalTrials.gov)
May 6, 202115/6/2020Examining Effects of Ocrevus on Cognitive Fatigue Using fMRIA Biomarker for Cognitive Fatigue Using Functional Imaging in MSMultiple Sclerosis, Relapsing-RemittingDrug: OcrevusKessler FoundationHackensack Meridian HealthRecruiting18 Years64 YearsAll60United States
87NCT05242731
(ClinicalTrials.gov)
April 29, 202123/1/2022Telemonitoring and Connected Care Applied to Multiple ScleroseMonSter Study, Telemonitoring and Connected Care Applied to Multiple ScleroseMultiple SclerosisDevice: MSmonitor, a self-management/education program with e-health interventions;Device: Video calling program Better-close;Device: Researchmanager programIsalaNULLRecruiting18 YearsN/AAll208N/ANetherlands
88NCT04688788
(ClinicalTrials.gov)
April 28, 202122/12/2020Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple SclerosisDanish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple SclerosisRelapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Rituximab;Drug: Ocrelizumab;Drug: Fexofenadine;Drug: Paracetamol;Drug: MethylprednisoloneRigshospitalet, DenmarkOdense University Hospital;Aarhus University Hospital;Aalborg University Hospital;Herlev Hospital;Hillerod Hospital, Denmark;Zealand University Hospital;Kolding Sygehus;Regional Hospital Holstebro;Hvidovre University Hospital;Hospital of South West Jutland, Esbjerg, Denmark;GCP unit, Copenhagen University Hospital;GCP-unit at Aarhus University Hospital, Aarhus, Denmark;Hospital of Southern Jutland, Sønderborg, Denmark;Hospital of Central Denmark Region, Viborg, Denmark;Danske RegionerRecruiting18 Years65 YearsAll594Phase 3Denmark
89NCT04843774
(ClinicalTrials.gov)
April 20, 20219/4/2021Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA)Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA)Multiple SclerosisDrug: SARS-COV-2 mRNA VaccineNYU Langone HealthNULLRecruiting18 Years65 YearsAll60United States
90NCT04792567
(ClinicalTrials.gov)
April 19, 20218/3/2021Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)An Open-label Multicenter Study to Assess Response to SARS-CoV-2 modRNA Vaccines in Participants With Secondary Progressive Multiple Sclerosis Treated With Mayzent (Siponimod)Secondary Progressive Multiple SclerosisDrug: BAF312;Drug: Baseline disease modifying therapies (DMTs)Novartis PharmaceuticalsNULLActive, not recruiting18 Years100 YearsAll41Phase 4Germany
91NCT04742400
(ClinicalTrials.gov)
April 15, 20215/2/2021Tolebrutinib, a Brain-penetrant Bruton s Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple SclerosisA Phase 2 Clinical Trial of Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple SclerosisMultiple SclerosisDrug: tolebrutinib 60mg;Drug: tolebrutinib 120mgNational Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll30Phase 2United States
92NCT04952766
(ClinicalTrials.gov)
March 29, 202116/6/2021Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy AdultsStudy Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy AdultsKidney Transplant;Myeloma;Cancer;Hematologic Malignancy;Multiple Sclerosis;Hypergammaglobulinemia;Malignant Tumor;Hiv;Diabetes Type 2Biological: Biological samplesCentre Hospitalier Régional d'OrléansNULLRecruiting18 YearsN/AAll240Phase 4France
93NCT04843813
(ClinicalTrials.gov)
March 26, 20217/4/2021Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-Lutein and Multiple Sclerosis Experimental Study (LuMES)Multiple SclerosisDietary Supplement: Lutein;Dietary Supplement: PlaceboUniversity of Illinois at Urbana-ChampaignDivision of Nutritional Sciences, University of Illinois at Urbana-Champaign;National Institutes of Health Rehabilitation Research Resource to Enhance Clinical Trials (REACT)Recruiting18 Years64 YearsAll60N/AUnited States
94NCT04699747
(ClinicalTrials.gov)
March 25, 202116/12/2020Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis SubjectsInvestigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis SubjectsMultiple SclerosisDrug: F-18 3F4APMassachusetts General HospitalNULLRecruiting18 Years65 YearsAll60Phase 1United States
95NCT04586023
(ClinicalTrials.gov)
March 24, 20218/10/2020Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: teriflunomide;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years55 YearsAll736Phase 3United States;Austria;Brazil;Bulgaria;Canada;Denmark;France;Greece;Guatemala;India;Italy;Korea, Republic of;Mexico;Poland;Russian Federation;Turkey;United Kingdom
96NCT04697407
(ClinicalTrials.gov)
March 23, 20214/1/2021IL-2 Signaling and Polarization of Regulatory LBs: Involvement in Multiple SclerosisBREGS - IL-2 Signaling and Polarization of Regulatory LBs: Involvement in Multiple SclerosisMultiple SclerosisBiological: Blood sampling;Biological: CSF samplingRennes University HospitalNULLRecruiting18 YearsN/AAll95N/AFrance
97NCT05075499
(ClinicalTrials.gov)
March 20, 20216/10/2021Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Treated With Teriflunomide and AlemtuzumabLONGEVITY OF IMMUNE RESPONSE TO COVID-19 VACCINE IN VACCINATED MULTIPLE SCLEROSIS PATIENTS TREATED WITH TERIFLUNOMIDE (AUBAGIO) OR ALEMTUZUMAB (LEMTRADA)Multiple SclerosisBiological: COVID-19 vaccinationSheba Medical CenterSanofiRecruiting18 YearsN/AAll70N/AIsrael
98NCT04565431
(ClinicalTrials.gov)
March 19, 202125/8/2020Examining Effects of Tysabri on Cognitive Fatigue Using fMRIBiomarker for Cognitive Fatigue Using Functional Imaging in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: TysabriKessler FoundationSt. Barnabas Medical CenterRecruiting18 Years64 YearsAll25United States
99NCT04586010
(ClinicalTrials.gov)
March 17, 20218/10/2020A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: teriflunomide;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years55 YearsAll736Phase 3United States;Argentina;China;Finland;Germany;Hong Kong;Hungary;Italy;Netherlands;Peru;Portugal;Russian Federation;Spain;Switzerland;Taiwan;Ukraine
100NCT04756687
(ClinicalTrials.gov)
March 10, 202112/2/2021Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by TecfideraA Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in FranceMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Dimethyl fumarateBiogenNULLCompleted18 YearsN/AAll1507France
101NCT04783935
(ClinicalTrials.gov)
March 10, 20213/3/2021Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)A 2-year Extension Study to Evaluate Long-term Effectiveness of Mavenclad® in Participants Who Have Completed Trial MS700568_0022 (MAGNIFY MS) (Magnify MS Extension)Multiple SclerosisDrug: Mavenclad®Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLRecruiting18 YearsN/AAll249Phase 4Australia;Austria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Poland;Spain;Sweden;United Kingdom
102NCT04660539
(ClinicalTrials.gov)
March 2, 202124/11/2020A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica Spectrum DisorderDrug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroidsHoffmann-La RocheNULLActive, not recruiting18 YearsN/AAll127Phase 3United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom
103NCT04650321
(ClinicalTrials.gov)
March 1, 202116/11/2020Home Based Infusions for OcrelizumabEvaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based InfusionsMultiple SclerosisDrug: Ocrelizumab at homeUniversity of Colorado, DenverGenentech, Inc.Recruiting18 Years55 YearsAll110Phase 4United States
104NCT04711148
(ClinicalTrials.gov)
March 1, 20218/1/2021A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological ActivityRelapsing Remitting Multiple SclerosisOther: placebo;Drug: orelabrutinibBeijing InnoCare Pharma Tech Co., Ltd.NULLRecruiting18 Years55 YearsAll160Phase 2United States;China;Poland;Ukraine
105NCT04390009
(ClinicalTrials.gov)
March 1, 202112/5/2020Entire-body PET Scans for Multiple SclerosisExploratory Study of Entire-body PET Scans for Multiple SclerosisMultiple SclerosisDiagnostic Test: Entire-body PET-CT scans;Drug: Amyvid radiopharmaceuticalBrain Health AllianceNULLNot yet recruiting25 Years55 YearsAll20Early Phase 1United States
106NCT04725175
(ClinicalTrials.gov)
February 26, 202118/1/2021Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy VolunteersA Phase I, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of PIPE-307 and Food Effect in Normal Healthy VolunteersMultiple SclerosisDrug: PIPE-307;Drug: Placebo oral tabletPipeline Therapeutics, Inc.NULLCompleted18 Years55 YearsAll70Phase 1Australia
107NCT04776213
(ClinicalTrials.gov)
February 23, 202126/2/2021Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)Multiple SclerosisDrug: Mavenclad®Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLRecruiting18 YearsN/AAll320Phase 4Austria;Czechia;Denmark;France;Hungary;Italy;Netherlands;Poland;Slovakia;Spain
108NCT04468165
(ClinicalTrials.gov)
February 23, 20218/7/2020Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA RegionEffectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA RegionRelapsing Remitting Multiple SclerosisDrug: Dimethyl Fumarate (DMF)Hikma Pharmaceuticals LLCNULLRecruiting18 YearsN/AAll155Algeria;Egypt;Jordan
109NCT04667949
(ClinicalTrials.gov)
February 20, 20218/12/2020Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) PatientsA 24-month, Open-label, Prospective, Multicenter Interventional, Single-arm Study Assessing the Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Relapsing Multiple Sclerosis (RMS) Patients in ChinaRelapsing Multiple Sclerosis (RMS)Drug: Fingolimod 0.5mgNovartis PharmaceuticalsNULLRecruiting10 Years65 YearsAll100Phase 4China
110NCT05286242
(ClinicalTrials.gov)
February 10, 202115/3/2022Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient PatientsEvaluating the Immune Response to COVID19 Vaccination in Immunodeficient PatientsMultiple Sclerosis;Autoimmune Blistering Disease;B-Cell DeficiencyBiological: COVID19 vaccineYale UniversityNational Institute of Allergy and Infectious Diseases (NIAID);Robert Leet and Clara Guthrie Patterson TrustActive, not recruiting18 YearsN/AAll400United States
111NCT04387734
(ClinicalTrials.gov)
February 5, 202111/5/2020Effects of Ocrevus in Relapsing Multiple SclerosisEffects and Mechanisms of Ocrevus on Ambulatory Functions in People With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Ocrelizumab;Drug: PlatformGeorgia State UniversityMultiple Sclerosis Center of AtlantaRecruiting18 Years65 YearsAll60Phase 4United States
112NCT02912897
(ClinicalTrials.gov)
January 26, 202113/9/2016Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy With Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients With a First Clinical Episode Highly Suggestive of Multiple SclerosisAn Open Single-center, Phase I Proof of Concept Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy With Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients With a First Clinical Episode Highly Suggestive of Multiple SclerosisMultiple SclerosisBiological: Cellular therapy with EBV specific autologous CTL infusionNantes University HospitalNULLRecruiting18 Years45 YearsAll7Phase 1France
113NCT04667117
(ClinicalTrials.gov)
January 14, 20218/12/2020A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With OfatumumabAn Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg SubcutaneouslyRelapsing Multiple SclerosisBiological: Quadrivalent influenza vaccine;Drug: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years55 YearsAll66Phase 4United States
114EUCTR2020-003874-30-IT
(EUCTR)
08/01/202124/05/2021Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
Product Name: Cladribine tablets
Product Code: [Not Applicable]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 4France;Czechia;Hungary;Slovakia;Spain;Poland;Denmark;Austria;Netherlands;Italy
115NCT02200718
(ClinicalTrials.gov)
December 31, 202017/7/2014A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple SclerosisA Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple SclerosisMultiple SclerosisBiological: NeuroVax;Biological: IFA Incomplete Freund's AdjuvantImmune Response BioPharma, Inc.NULLNot yet recruiting5 Years17 YearsAll12Phase 1United States
116NCT04670770
(ClinicalTrials.gov)
December 24, 202010/12/2020An Open Label Study of the Effects of SHR1459 in NMOSDs PatientsAn Open Label Phase II Clinical Trial Evaluating the Efficacy and Safety of SHR1459 in Adult Patients With Neuromyelitis Optical Spectrum Disorders (NMOSDs)Neuromyelitis Optica Spectrum DisordersDrug: Drug - SHR1459Reistone Biopharma Company LimitedNULLActive, not recruiting18 Years75 YearsAll10Phase 2China
117NCT04657666
(ClinicalTrials.gov)
December 21, 202011/11/2020Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients With Multiple SclerosisA 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 SclerosisSpasticity in Participants With Multiple SclerosisDrug: Nabiximols;Drug: PlaceboGW Pharmaceuticals Ltd.NULLRecruiting18 YearsN/AAll52Phase 3Czechia;Poland
118NCT04640818
(ClinicalTrials.gov)
December 17, 202018/11/2020Safety and Efficacy of Cladribine Therapy After Anti CD20 TherapySafety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot StudyMultiple SclerosisDrug: Cladribine Oral Tablet;Drug: Rituximab;Drug: OcrelizumabClaudio GobbiMerck AG SwitzerlandRecruiting18 Years80 YearsAll45Switzerland
119NCT04548999
(ClinicalTrials.gov)
December 3, 20209/9/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: Antihistamine;Drug: MethylprednisoloneHoffmann-La RocheNULLRecruiting18 Years55 YearsAll699Phase 3United States;Argentina;Belgium;Brazil;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Peru;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
120NCT04544436
(ClinicalTrials.gov)
November 26, 20204/9/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: Antihistamine;Drug: MethylprednisoloneHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll786Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czechia;Israel;Mexico;Netherlands
121NCT05283551
(ClinicalTrials.gov)
November 25, 202024/2/2022Famciclovir in Multiple SclerosisA Phase 2 Open Label Clinical Trial to Determine the Effect of Famciclovir on Epstein-Barr Virus Activity as Measured by EBV Shedding in Saliva of Patients With Multiple Sclerosis.Multiple SclerosisDrug: FamciclovirQueen Mary University of LondonNULLRecruiting18 YearsN/AAll30Phase 2United Kingdom
122NCT04356339
(ClinicalTrials.gov)
November 24, 202019/4/2020US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT AutoinjectorUS PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ AutoinjectorMultiple SclerosisDrug: Interferon-beta-1b (BETASERON, BAY 86-5046)BayerNULLCompleted18 YearsN/AAll100United States
123NCT04602390
(ClinicalTrials.gov)
November 6, 20205/10/2020Assessment of ANK-700 in Patients With Relapsing Remitting Multiple SclerosisA Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis;Relapsing Remitting Multiple SclerosisDrug: ANK-700;Drug: PlaceboAnokion SANULLRecruiting18 Years55 YearsAll33Phase 1United States
124NCT04578639
(ClinicalTrials.gov)
November 2, 202022/9/2020Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS DiseaseOcrelizumab VErsus Rituximab Off-Label at the Onset of RelapsingRelapsing Remitting Multiple SclerosisDrug: Rituximab;Drug: OcrelizumabHaukeland University HospitalUniversity Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North NorwayRecruiting18 Years60 YearsAll211Phase 3Norway
125NCT04150549
(ClinicalTrials.gov)
November 202011/10/2019FMT for MS PatientsFecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized TrialMultiple SclerosisBiological: Fecal Microbial TransplantsLawson Health Research InstituteNULLNot yet recruiting18 Years55 YearsAll34Phase 2NULL
126NCT04601142
(ClinicalTrials.gov)
October 31, 202015/10/2020Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene PolymorphismStudy on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort StudyGlucocorticoid Resistance;Gene;Neuromyelitis OpticaDrug: MethylprednisoloneBeijing Tongren HospitalNULLRecruiting16 Years80 YearsAll350China
127NCT04593927
(ClinicalTrials.gov)
October 28, 202014/10/2020Long Term Special Drug Use-results Surveillance for Mayzent in SPMS PatientsLong Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)Secondary Progressive Multiple Sclerosis (SPMS)Drug: MayzentNovartis PharmaceuticalsNULLRecruitingN/A99 YearsAll330Japan
128NCT04855617
(ClinicalTrials.gov)
October 26, 202019/4/2021Symptom Burden in Patients Treated With Ocrelizumab for Multiple SclerosisSymptom Burden in Patients Treated With Ocrelizumab for Multiple SclerosisMultiple SclerosisDrug: OcrelizumabNYU Langone HealthGenentech, Inc.Active, not recruiting18 Years80 YearsAll122United States
129NCT04544449
(ClinicalTrials.gov)
October 26, 20204/9/2020A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple SclerosisA Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.Multiple Sclerosis, Primary ProgressiveDrug: fenebrutinib;Drug: ocrelizumab;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years65 YearsAll946Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Colombia;Denmark;France;Greece;Hungary;Israel;Mexico;Peru;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Belgium;Czechia;Germany;Italy;New Zealand
130NCT04626921
(ClinicalTrials.gov)
October 22, 202030/10/2020A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple SclerosisVISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: CNM-Au8Clene NanomedicineGeorge ClinicalActive, not recruiting18 Years55 YearsAll150Phase 2/Phase 3Australia
131NCT04832269
(ClinicalTrials.gov)
October 19, 202018/2/2021Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and BehaviourEffects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain DevelopmentMultiple SclerosisOther: Exposure to methylprednisolone during pregnancyJena University HospitalRuhr University of Bochum;Interdisciplinary Center of Clinical Research of the Medical Faculty Jena;Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyRecruiting8 Years18 YearsAll80Germany
132EUCTR2019-001829-26-DE
(EUCTR)
19/10/202008/01/2020A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Soliris
Product Name: Soliris
Product Code: Soliris
INN or Proposed INN: ECULIZUMAB
Other descriptive name: h5G1.1-mAb
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2;Phase 3United States;Canada;Spain;Germany;Italy;Japan;Korea, Republic of
133NCT04486716
(ClinicalTrials.gov)
October 19, 202023/7/2020A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple SclerosisA Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS)Relapsing Multiple SclerosisDrug: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years60 YearsAll100Phase 3United States;Puerto Rico
134NCT04480853
(ClinicalTrials.gov)
October 12, 202017/7/2020Safety and Efficacy Study of Fingolimod in Taiwanese Adults (= 20years) With Relapsing Remitting Multiple SclerosisA 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 SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLRecruiting20 YearsN/AAll30Phase 4Taiwan
135EUCTR2019-003352-37-PL
(EUCTR)
05/10/202006/07/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Ravulizumab
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
136NCT04203498
(ClinicalTrials.gov)
October 1, 202017/12/2019Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple SclerosisA 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 SclerosisMultiple Sclerosis (MS)Drug: Nabiximols;Drug: PlaceboGW Pharmaceuticals Ltd.NULLRecruiting18 YearsN/AAll446Phase 3United States;Czechia;Poland
137NCT04411641
(ClinicalTrials.gov)
September 24, 202028/5/2020Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisDrug: Tolebrutinib;Drug: Placebo to match TolebrutinibSanofiNULLRecruiting18 Years60 YearsAll1290Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Lithuania;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Spain;Turkey;Ukraine;United Kingdom
138NCT04561557
(ClinicalTrials.gov)
September 22, 202010/9/2020Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous SystemAn Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous SystemAutoimmune Diseases;Autoimmune Diseases of the Nervous System;Neuromyelitis Optica Spectrum DisorderBiological: CT103A cells;Drug: Cyclophosphamide and fludarabineTongji HospitalNanjing IASO Biotherapeutics Co.,LtdRecruiting18 Years75 YearsAll12Early Phase 1China
139NCT04510220
(ClinicalTrials.gov)
September 21, 202031/7/20209-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple SclerosisOpen-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: Ofatumumab;Drug: [F-18]PBR06Brigham and Women's HospitalNovartisRecruiting18 Years60 YearsAll10Phase 3United States
140NCT05080270
(ClinicalTrials.gov)
September 21, 20205/10/2021Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple SclerosisFeasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple SclerosisBiological: Tolerogenic FibroblastsFibroBiologicsNULLCompleted18 Years55 YearsAll5Early Phase 1Mexico
141NCT04550455
(ClinicalTrials.gov)
September 16, 20202/9/2020A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine TabletsA Prospective Biomarker Study in Active Secondary Progressive Multiple Sclerosis (SPMS)Subjects Treated With Cladribine TabletsMultiple SclerosisDrug: Cladribine TabletsKeith Edwards, M.D.EMD SeronoRecruiting21 Years65 YearsAll30Phase 4United States
142NCT04528121
(ClinicalTrials.gov)
September 15, 202022/8/2020Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple SclerosisEffect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingOther: CoDuSe balance training and step square exercises;Other: conventional balance trainingLama Saad El-Din MahmoudNULLCompleted20 Years40 YearsAll52N/AEgypt
143NCT05019248
(ClinicalTrials.gov)
September 1, 202019/8/2021Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving CladribineA Non-interventional Observation Study to Evaluate Immune Responses Following Seasonal Influenza Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Cladribine TabletsMultiple Sclerosis, Relapsing-Remitting;Vaccine Response ImpairedBiological: Most recent vaccine to seasonal influenzaHeinrich-Heine University, DuesseldorfNULLRecruiting18 Years60 YearsAll260Germany
144NCT04580381
(ClinicalTrials.gov)
September 1, 20202/10/2020Real World Effectiveness of Natalizumab Extended Interval Dosing in a French CohortReal World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French CohortMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab Injection [Tysabri]University Hospital, CaenBiogenCompleted18 YearsN/AAll500France
145NCT04466150
(ClinicalTrials.gov)
August 30, 20207/7/2020Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis OnsetImpact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis OnsetRelapsing Multiple Sclerosis;Clinically Isolated SyndromeDrug: OcrelizumabUniversity of California, San FranciscoGenentech, Inc.;Valhalla Charitable FoundationRecruiting18 Years50 YearsAll30Phase 4United States
146NCT04458051
(ClinicalTrials.gov)
August 13, 20201/7/2020Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)Primary Progressive Multiple SclerosisDrug: Tolebrutinib;Drug: PlaceboSanofiNULLRecruiting18 Years55 YearsAll990Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Latvia;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
147NCT04964791
(ClinicalTrials.gov)
August 1, 202027/6/2021RMS Study of BTK Inhibitor SAR442168A Phase 3, Randomed, Double-blind Efficacy and Safety Comparing SAR442168 and Terfluramide (Aubaglo®) in Particpants With Relapsing Forms of Multiple Sclerosis (GEMINI1)Relapsing Multiple SclerosisDrug: SAR442168Peking University Third HospitalNULLRecruiting18 Years55 YearsAll900Phase 3China
148NCT04261790
(ClinicalTrials.gov)
August 1, 20206/2/2020Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple SclerosisEvaluating the Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: OcrelizumabJohns Hopkins UniversityGenentech, Inc.Active, not recruiting18 Years99 YearsAll10Phase 4United States
149NCT04377555
(ClinicalTrials.gov)
July 30, 20201/5/2020Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab.An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With OcrelizumabMultiple Sclerosis, RelapsingDrug: OcrelizumabGenentech, Inc.NULLRecruiting18 Years65 YearsAll150Phase 4United States;Kenya;Puerto Rico
150NCT04353492
(ClinicalTrials.gov)
July 14, 202016/4/2020An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to OfatumumabA 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 TherapyRelapsing Multiple SclerosisBiological: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years60 YearsAll550Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Estonia;Germany;Greece;Hungary;Italy;Latvia;Lebanon;Mexico;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Slovakia;Slovenia;Spain;Switzerland;Turkey;United Kingdom
151NCT04338061
(ClinicalTrials.gov)
July 2, 20206/4/2020Study of Evobrutinib in Participants With RMS (evolutionRMS 2)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 (evolutionRMS 2)Relapsing Multiple SclerosisDrug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib)Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyEMD Serono Research & Development Institute, Inc.Active, not recruiting18 Years55 YearsAll930Phase 3United States;Belarus;Brazil;Bulgaria;Canada;France;Germany;Greece;India;Italy;Latvia;Lithuania;Malaysia;Moldova, Republic of;Norway;Philippines;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;Turkey;Ukraine
152NCT04260711
(ClinicalTrials.gov)
July 1, 202021/1/2020Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS).The Safety and Cost-effectiveness of Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS): a Randomized Rater-blinded Multicenter Trial.Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary ProgressiveDrug: DMTVU University Medical CenterNULLRecruiting18 YearsN/AAll130N/ANetherlands
153NCT04459988
(ClinicalTrials.gov)
July 1, 202030/6/2020Mechanistic Study of OcrevusEnhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple SclerosisMultiple SclerosisDrug: OcrelizumabUniversity of MichiganNULLRecruiting18 Years65 YearsAll35United States
154NCT04458688
(ClinicalTrials.gov)
July 202030/6/2020Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple SclerosisInvestigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) StudyMultiple Sclerosis, Relapsing-RemittingOther: Observation of Ocrelizumab as Treatment in RRMS PatientsWayne State UniversityNULLNot yet recruiting18 Years60 YearsAll80NULL
155NCT04410978
(ClinicalTrials.gov)
June 30, 202028/5/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: Tolebrutinib;Drug: Teriflunomide HMR1726;Drug: Placebo to match Tolebrutinib;Drug: Placebo to match TeriflunomideSanofiNULLRecruiting18 Years55 YearsAll900Phase 3United States;Austria;Belarus;Bulgaria;Canada;China;Czechia;Denmark;Estonia;Finland;Germany;Italy;Japan;Lithuania;Mexico;Poland;Romania;Russian Federation;Spain;Sweden;Taiwan;Turkey;Ukraine
156EUCTR2019-001829-26-IT
(EUCTR)
19/06/202022/01/2021A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD).A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder. - NA Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML)
Product Name: Soliris
Product Code: [Soliris]
INN or Proposed INN: ECULIZUMAB
Trade Name: MENVEO
Product Name: MENVEO
Product Code: [NA]
Other descriptive name: N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197
Trade Name: Bexsero
Product Name: Bexsero
Product Code: [NA]
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
Trade Name: Hiberix
Product Name: Hiberix
Product Code: [NA]
Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)
Trade Name: Prevenar 13
Product Name: Prevenar 13
Product Code: [NA]
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED)
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2;Phase 3United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of
157NCT04480307
(ClinicalTrials.gov)
June 17, 202010/7/2020Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple SclerosisA Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)Multiple SclerosisDrug: temelimab 18 mg/kg;Drug: temelimab 36 mg/kg;Drug: temelimab 54 mg/kg;Drug: PlaceboGeNeuro Innovation SASNULLActive, not recruiting18 Years55 YearsAll41Phase 2Sweden
158NCT04338022
(ClinicalTrials.gov)
June 12, 20206/4/2020Study of Evobrutinib in Participants With RMS (evolutionRMS 1)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 (evolutionRMS 1)Relapsing Multiple SclerosisDrug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib)Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyEMD Serono Research & Development Institute, Inc.Active, not recruiting18 Years55 YearsAll930Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;Taiwan
159NCT04410991
(ClinicalTrials.gov)
June 11, 202028/5/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: Tolebrutinib;Drug: Teriflunomide HMR1726;Drug: Placebo to match Tolebrutinib;Drug: Placebo to match TeriflunomideSanofiNULLRecruiting18 Years55 YearsAll900Phase 3United States;Argentina;Belgium;Brazil;Canada;Chile;Croatia;Czechia;France;Germany;Greece;Hungary;India;Israel;Korea, Republic of;Latvia;Netherlands;Norway;Portugal;Puerto Rico;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom
160EUCTR2019-003352-37-NL
(EUCTR)
11/06/202024/02/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
161NCT04410965
(ClinicalTrials.gov)
May 20, 202028/5/2020Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 WeeksEvaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 WeeksMultiple SclerosisDrug: TERIFLUNOMIDESanofiNULLCompleted18 Years55 YearsAll82Phase 4China
162NCT05141669
(ClinicalTrials.gov)
May 18, 202019/11/2021Impact of Fingolimod Adherence on OutcomesImpact of Fingolimod Adherence on OutcomesMultiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLCompleted18 Years85 YearsAll694United States
163NCT04391023
(ClinicalTrials.gov)
May 15, 202012/5/2020Cerebellar tDCS and Balance Training in PwMSThe Effects of 2 mA and 4 mA Cerebellar Transcranial Direct Current Stimulation and Balance Training to Reduce Fall Risk in People With Multiple SclerosisMultiple SclerosisDevice: Sham Transcranial Direct Current Stimulation (tDCS);Behavioral: Balance Training;Device: 2 mA Transcranial Direct Current Stimulation;Device: 4 mA Transcranial Direct Current StimulationUniversity of IowaNULLNot yet recruiting18 Years70 YearsAll30N/AUnited States
164NCT05081700
(ClinicalTrials.gov)
May 11, 202013/11/2020A Systems Approach to Understanding Disease Processes in Multiple SclerosisA Systems Approach to Understanding Disease Processes in Multiple SclerosisMultiple SclerosisDrug: All patients in the study will be treated with ocrelizumabProvidence Health & ServicesInstitute for Systems Biology;Genentech, Inc.Active, not recruiting18 Years60 YearsAll50United States
165EUCTR2019-003352-37-DE
(EUCTR)
11/05/202006/01/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3Germany;Netherlands;Japan;Korea, Republic of;United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark
166EUCTR2018-000620-34-DE
(EUCTR)
06/05/202008/11/2019Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Germany;Sweden
167NCT03404388
(ClinicalTrials.gov)
April 1, 202011/1/2018Brain and Behavioral Influences on Motor Skill Learning in Multiple SclerosisBrain and Behavioral Influences on Motor Skill Learning in Multiple SclerosisMultiple SclerosisBehavioral: Balance TrainingWayne State UniversityNULLEnrolling by invitation18 Years65 YearsAll150N/AUnited States
168NCT04267926
(ClinicalTrials.gov)
April 1, 202011/2/2020MitoQ for Fatigue in Multiple Sclerosis (MS)MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled TrialMultiple Sclerosis;FatigueDrug: 20 mg MitoQ;Drug: Placebo;Drug: 40mg of MitoQVA Office of Research and DevelopmentNULLRecruiting18 Years70 YearsAll60Phase 1/Phase 2United States
169NCT04227470
(ClinicalTrials.gov)
March 31, 202021/11/2019A Study of HBM9161 in NMOSD PatientsSafety, Tolerability, Pharmacodynamics and Efficacy of HBM9161 Weekly Subcutaneous Administration in Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD) in ChinaNMO Spectrum DisorderDrug: HBM9161 InjectionHarbour BioMed (Guangzhou) Co. Ltd.NULLRecruiting18 YearsN/AAll12Phase 1China
170EUCTR2019-001549-42-GB
(EUCTR)
27/03/202003/02/2020Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MSA multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS Highly active relapsing remitting multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide monohydrate
INN or Proposed INN: Cyclophosphamide monohydrate
Product Name: Filgrastim
INN or Proposed INN: Filgrastim
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
Trade Name: Alemtuzumab
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Product Name: Lenograstim
INN or Proposed INN: Lenograstim
Trade Name: Ocrelizumab
Product Name: Ocrelizumab
Sheffield Teaching HospitalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
198Phase 3United Kingdom
171EUCTR2019-003352-37-AT
(EUCTR)
27/03/202013/02/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
55Phase 3Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of;France;Italy;United Kingdom;Russian Federation;Austria;Turkey;Spain;United States
172EUCTR2016-001166-29-DE
(EUCTR)
18/03/202012/08/2019A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST)A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) - COAST 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] - Immune System Diseases [C20]
Trade Name: Lemtrada
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: ALEMTUZUMAB
Trade Name: Ocrevus
Product Name: ocrelizumab
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
Product Name: autologous hematopoietic stem cells
Product Code: aHSC
University Medical Centre Hamburg-EppendorfNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Germany
173NCT04144257
(ClinicalTrials.gov)
March 12, 202028/10/2019Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related FatigueRole of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related FatigueMultiple SclerosisDrug: [F-18]PBR06;Drug: [C-11]MethylreboxetineBrigham and Women's HospitalU.S. Army Medical Research Acquisition ActivityRecruiting18 Years60 YearsAll12Phase 1/Phase 2United States
174NCT04038541
(ClinicalTrials.gov)
March 11, 20207/6/2019Prebiotic vs Probiotic in Multiple SclerosisPrebiotic and Probiotic Treatment Trial in Multiple SclerosisMultiple Sclerosis;Clinically Isolated Syndrome (CIS)Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac);Dietary Supplement: Probiotics (Visbiome®)Columbia UniversityNULLRecruiting18 YearsN/AAll20N/AUnited States
175NCT02057159
(ClinicalTrials.gov)
March 9, 20204/2/2014A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple SclerosisA Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple SclerosisSecondary Progress Multiple Sclerosis;Multiple SclerosisBiological: NeuroVax;Biological: IFA PlaceboImmune Response BioPharma, Inc.croRecruiting18 Years50 YearsAll200Phase 2/Phase 3United States
176NCT02149706
(ClinicalTrials.gov)
March 9, 202024/5/2014A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple SclerosisA Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via VaccinationMultiple SclerosisBiological: NeuroVax;Biological: IFA Incomplete Freund's AdjuvantImmune Response BioPharma, Inc.croNot yet recruiting18 Years70 YearsAll150Phase 2United States
177EUCTR2019-003352-37-IT
(EUCTR)
04/03/202017/06/2021A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSDA Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - NA Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultromiris
Product Name: Ravulizumab
Product Code: [ALXN1210]
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of
178EUCTR2019-003352-37-ES
(EUCTR)
25/02/202014/01/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
179NCT04121468
(ClinicalTrials.gov)
February 24, 20202/10/2019A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children With Multiple SclerosisA Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children With Multiple SclerosisMultiple Sclerosis (MS)Drug: Metformin;Other: PlaceboThe Hospital for Sick ChildrenQueen's University;Ontario Institute for Regenerative Medicine;Unity Health Toronto;Stem Cell Network;Multiple Sclerosis Society of CanadaRecruiting10 Years25 YearsAll30Phase 1/Phase 2Canada
180NCT04242056
(ClinicalTrials.gov)
February 20, 202021/1/2020To Study the Pathophysiological Features of Multiple SclerosisTo Study the Pathophysiological Features of Multiple Sclerosis: Combined Multi-modalities of Amyloid and Tau Images Associated With Serum Neurofilament Light Chain LevelsMultiple Sclerosis;Neurofilament Light Chain;Glial Fibrillary Acidic ProteinDrug: 18F-PM-PBB3Chang Gung Memorial HospitalNULLNot yet recruiting20 Years70 YearsAll38Phase 1/Phase 2NULL
181NCT04178005
(ClinicalTrials.gov)
February 19, 202021/11/2019Cladribine Tablets After Treatment With Natalizumab (CLADRINA)Cladribine Tablets After Treatment With Natalizumab (CLADRINA)Multiple SclerosisDrug: CladribineUniversity of Texas Southwestern Medical CenterEMD SeronoRecruiting18 Years60 YearsAll40Phase 4United States
182NCT04175834
(ClinicalTrials.gov)
February 5, 202022/11/2019Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to OcrelizumabComparing the Risk and Severity of Infusion-Related Reactions in Patients Premedicated With Cetirizine Versus Diphenhydramine Prior to Ocrelizumab InfusionsMultiple Sclerosis;Infusion ReactionDrug: antihistamineProvidence Health & ServicesGenentech, Inc.Active, not recruiting18 Years70 YearsAll52Phase 3United States
183NCT04267185
(ClinicalTrials.gov)
February 4, 202016/1/2020A Dyadic Approach for Promoting Physical Activity Among People With MS and Their Support PartnersPhysical Activity Together for MS (PAT-MS): Pilot Study of a Dyadic Rehabilitation Intervention for People With Moderate-to-Severe Multiple Sclerosis Disability and Their Family CaregiversMultiple SclerosisBehavioral: Physical Activity Together for PwMS and their CGs (PAT-MS)University of OttawaThe Ottawa Hospital;Consortium of Multiple Sclerosis CentersRecruiting18 YearsN/AAll40N/ACanada
184NCT04225312
(ClinicalTrials.gov)
February 3, 20203/1/2020Personalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple SclerosisPersonalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Personalized extended interval dosing of natalizumab;Drug: Standard interval dosingVU University Medical CenterStichting MS Research;Innovatiefonds ZorgverzekeraardRecruiting18 YearsN/AAll300Phase 4Netherlands
185NCT04230174
(ClinicalTrials.gov)
February 202013/1/2020Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia ActivationEffect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia ActivationMultiple SclerosisDrug: 11C-PBR28Massachusetts General HospitalGenentech, Inc.Not yet recruiting18 Years65 YearsAll24Phase 4NULL
186NCT04291456
(ClinicalTrials.gov)
January 31, 202018/11/2019Minocycline in MS: Confirmation of BenefitOpen-Label Trial of Minocycline in Early Multiple Sclerosis: Confirmation of Treatment BenefitMultiple Sclerosis;Clinically Isolated SyndromeDrug: Minocycline 100mgUniversity of CalgaryHotchkiss Brain Institute, University of CalgaryRecruiting18 Years60 YearsAll148Phase 3Canada
187NCT03983720
(ClinicalTrials.gov)
January 21, 20207/6/2019Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?Sclerosis, MultipleOther: Evaluation of degree chronic fatigue.;Other: Questionnaires;Biological: Blood sample;Other: Cardiopulmonary evaluation;Device: Capacity of muscular oxygen extraction;Device: Sleep assessment;Device: Metabolic fatigue;Other: Neuromuscular evaluationCentre Hospitalier Universitaire de Saint EtienneNULLRecruiting18 Years70 YearsAll60Phase 2France
188NCT04140305
(ClinicalTrials.gov)
January 16, 202024/10/2019Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)Multiple SclerosisDrug: RPC-1063CelgeneNULLRecruiting18 Years65 YearsAll250Phase 3United States;Canada;Puerto Rico
189EUCTR2019-003352-37-DK
(EUCTR)
15/01/202019/12/2019Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Ravulizumab
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
190NCT04155424
(ClinicalTrials.gov)
January 14, 20205/11/2019A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum DisorderA Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum DisorderNeuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: EculizumabAlexion PharmaceuticalsNULLRecruiting2 Years17 YearsAll15Phase 2/Phase 3United States;Canada;Germany;Italy;Japan;Korea, Republic of;Spain
191NCT04075266
(ClinicalTrials.gov)
January 9, 202014/8/2019A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple SclerosisAn Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: OcrelizumabHoffmann-La RocheNULLRecruiting10 Years18 YearsAll36Phase 2United States;Italy;Poland
192NCT04178980
(ClinicalTrials.gov)
January 1, 202025/11/2019Role of Simvastatin in Relapsing-Remitting Multiple SclerosisDouble-blinded, Randomized Controlled Trial of Simvastatin Use As Adjuvant Therapy in Relapsing-Remitting Multiple SclerosisSimvastatin Multiple SclerosisDrug: Simvastatin in relapsing remitting multiple sclerosisAssiut UniversityNULLNot yet recruiting18 Years65 YearsAll60Phase 1NULL
193NCT03993171
(ClinicalTrials.gov)
December 19, 201931/5/201931P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis.A Phase 2, Open-Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: gold nanocrystalsClene NanomedicineUniversity of Texas Southwestern Medical CenterRecruiting18 Years55 YearsAll30Phase 2United States
194NCT04047628
(ClinicalTrials.gov)
December 19, 20195/8/2019Best Available Therapy Versus Autologous Hematopoetic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)Relapsing Multiple Sclerosis;Relapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple SclerosisProcedure: Autologous Hematopoietic Stem Cell Transplantation;Biological: Best Available Therapy (BAT)National Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Blood and Marrow Transplant Clinical Trials Network;PPD;Rho Federal Systems Division, Inc.Recruiting18 Years55 YearsAll156Phase 3United States;United Kingdom
195EUCTR2019-001829-26-ES
(EUCTR)
18/12/201906/11/2019 A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Soliris
INN or Proposed INN: ECULIZUMAB
Other descriptive name: h5G1.1-mAb
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of
196NCT04201262
(ClinicalTrials.gov)
December 13, 201911/12/2019An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSDA Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderBiological: RavulizumabAlexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll58Phase 3United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain;United Kingdom
197NCT04934800
(ClinicalTrials.gov)
December 10, 201917/6/2021Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)Multiple SclerosisDrug: CladribineMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyMerck Hellas sa., Greece, an affiliate of Merck KGaA, Darmstadt, GermanyActive, not recruiting18 YearsN/AAll242Greece;Italy;Norway;Poland;Portugal;Switzerland;Austria
198NCT04211740
(ClinicalTrials.gov)
December 6, 201917/12/2019Phase II Clinical Trial of OCH-NCNP1Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary ProgressiveDrug: OCH-NCNP1;Drug: PlaceboNational Center of Neurology and Psychiatry, JapanNULLEnrolling by invitation20 Years65 YearsAll30Phase 2Japan
199NCT04130997
(ClinicalTrials.gov)
November 18, 201916/10/2019An Extension Study of Ublituximab in Participants With Relapsing Multiple SclerosisAn Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple SclerosisRelapsing Multiple Sclerosis (RMS)Biological: UblituximabTG Therapeutics, Inc.NULLEnrolling by invitation18 YearsN/AAll900Phase 3United States;Belarus;Croatia;Georgia;Poland;Russian Federation;Serbia;Ukraine
200NCT04146285
(ClinicalTrials.gov)
November 5, 201926/9/2019A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum DisordersA Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum DisordersNeuromyelitis Optica Spectrum DisordersDrug: BAT4406FBio-Thera SolutionsNULLNot yet recruiting18 Years65 YearsAll48Phase 1China
201NCT03829566
(ClinicalTrials.gov)
November 20191/2/2019Autologous Transplant To End NMO Spectrum DisorderAutologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Devic's Disease;NMO Spectrum DisorderDrug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLWithdrawn18 Years65 YearsAll0Phase 2/Phase 3United States
202NCT03963375
(ClinicalTrials.gov)
October 28, 201923/5/2019Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple SclerosisCladribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System Biomarkers in Multiple SclerosisMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: CladribineWashington University School of MedicineEMD SeronoRecruiting18 Years65 YearsAll50Phase 4United States
203NCT04096443
(ClinicalTrials.gov)
October 28, 20197/8/2019Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple SclerosisA Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple SclerosisMultiple SclerosisBiological: Fecal microbial transplant (FMT)Griffin HospitalYale-Griffin Prevention Research Center;Multiple Sclerosis Treatment Center, Derby, ConnecticutRecruiting18 Years40 YearsAll15Early Phase 1United States
204NCT04025554
(ClinicalTrials.gov)
October 25, 201918/7/2019Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple SclerosisAnakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple SclerosisMultiple SclerosisDrug: AnakinraNational Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll10Phase 1/Phase 2United States
205NCT03958877
(ClinicalTrials.gov)
October 18, 201920/5/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label ExtensionMultiple Sclerosis, Relapsing-RemittingDrug: BIIB017 (peginterferon beta-1a);Drug: Interferon beta type 1aBiogenNULLRecruiting10 Years18 YearsAll142Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Croatia;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Kuwait;Portugal;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Tunisia;Turkey
206NCT04121403
(ClinicalTrials.gov)
October 16, 201923/9/2019Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) A Prospective Randomized Open-label Blinded Endpoint (PROBE) Multicenter Non-inferiority StudyRelapsing Multiple Sclerosis;Multiple SclerosisBiological: Rituximab;Drug: CladribineOslo University HospitalUniversity of Oslo;Göteborg University;Sykehuset Ostfold;Sykehuset Telemark;Vestre Viken Hospital Trust;Sorlandet Hospital HF;Helse Stavanger HF;Sykehuset Innlandet HF;Sykehuset i Vestfold HF;Helse Forde;University Hospital of North Norway;St. Olavs HospitalRecruiting18 Years65 YearsAll264Phase 3Norway
207NCT04129736
(ClinicalTrials.gov)
October 10, 201915/10/2019Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple SclerosisDetermination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.Multiple Sclerosis, PharmacokineticsDrug: Teriflunomide 14 MGJan LyckeNULLRecruiting18 Years65 YearsAll12Phase 4Sweden
208NCT04115488
(ClinicalTrials.gov)
October 1, 201910/9/2019Efficacy 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) infusionsPolpharma Biologics S.A.NULLActive, not recruiting18 Years60 YearsAll260Phase 3Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine
209NCT04062331
(ClinicalTrials.gov)
October 1, 20191/8/2019Transcranial Magnetic Stimulation (TMS) in Multiple SclerosisClinical and Neurochemical Effects of Transcranial Magnetic Stimulation (TMS) in Multiple SclerosisMultiple SclerosisDevice: Transcranial Magnetic Stimulation (TMS);Drug: PlacebosMaimónides Biomedical Research Institute of CórdobaIsaac Tunez-Fiñana;Eduardo Agüera-MoralesNot yet recruiting14 YearsN/AAll90Phase 1/Phase 2NULL
210EUCTR2017-001362-25-NL
(EUCTR)
30/09/201910/09/2019 Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS Relapsing remitting multiple sclerosis.
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: Thymoglobuline®
Product Name: Thymoglobuline®
INN or Proposed INN: ANTITHYMOCYTE IMMUNOGLOBULIN
Other descriptive name: ANTITHYMOCYTE IMMUNOGLOBULIN
Trade Name: Lemtrada
INN or Proposed INN: ALEMTUZUMAB
Other descriptive name: ALEMTUZUMAB
Trade Name: Mavenclad
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Trade Name: Ocrevus
Product Name: Ocrelizumab
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noDenmark;Netherlands
211NCT03996291
(ClinicalTrials.gov)
September 23, 201920/6/2019Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple SclerosisLong-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: TolebrutinibSanofiNULLActive, not recruiting18 Years55 YearsAll125Phase 2United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Spain;Ukraine
212NCT04035889
(ClinicalTrials.gov)
September 23, 201925/7/2019Melatonin for Sleep in MSA Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)Multiple SclerosisDietary Supplement: Melatonin;Dietary Supplement: PlaceboUniversity of California, San FranciscoNULLCompleted20 Years70 YearsAll30N/AUnited States
213NCT04121221
(ClinicalTrials.gov)
September 19, 20198/10/2019A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMSA Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to PlaceboMultiple Sclerosis, Relapsing-RemittingDrug: GA Depot;Other: PlaceboMapi Pharma Ltd.NULLActive, not recruiting18 Years55 YearsAll1016Phase 3United States;Belarus;Bosnia and Herzegovina;Bulgaria;Estonia;Georgia;Israel;Moldova, Republic of;Russian Federation;Ukraine
214NCT04032171
(ClinicalTrials.gov)
September 10, 201923/7/2019Study of Evobrutinib in Participants With Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing-remitting Multiple SclerosisDrug: Evobrutinib;Drug: Avonex®;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years55 YearsAll1Phase 3United States;Germany
215NCT04032158
(ClinicalTrials.gov)
August 26, 201923/7/2019Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing-remitting Multiple SclerosisDrug: Evobrutinib;Drug: Avonex®;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years55 YearsAll3Phase 3United States;Germany;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;Mexico;Montenegro;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine;United Kingdom
216NCT04221191
(ClinicalTrials.gov)
August 19, 20196/1/2020Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEPStudy on the Dimethyl Fumarate (DMF, Tecfidera®) Persistence of Remitting-relapsing Multiple Sclerosis (RR-MS) Patients Included in the French Patient Support Program (PSP) OroSEPMultiple Sclerosis, Relapsing-RemittingDrug: Dimethyl Fumarate;Other: PSPBiogenNULLRecruiting18 Years55 YearsAll350France
217NCT04966338
(ClinicalTrials.gov)
August 19, 201927/6/2021Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple SclerosisA Phase III, Randomized, Two-armed, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate Equivalency of the Efficacy and Safety of Ocrelizumab (CinnaGen, Iran) in Comparison to Reference Product, Ocrevus® (Roche, Switzerland) in Patients With Relapsing Multiple SclerosisMultiple Sclerosis;Relapsing-RemittingBiological: Ocrelizumab (CinnaGen, Iran);Biological: Ocrelizumab (Roche, Switzerland)CinnagenNULLActive, not recruiting18 Years55 YearsAll170Phase 3Iran, Islamic Republic of
218NCT03961204
(ClinicalTrials.gov)
August 15, 201922/5/2019Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials (CLASSIC-MS)Multiple Sclerosis (MS)Drug: CladribineEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompleted18 Years65 YearsAll662Phase 4United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;Italy;Korea, Republic of;Lebanon;Lithuania;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Tunisia;Ukraine;United Kingdom
219NCT03972306
(ClinicalTrials.gov)
August 12, 201929/5/2019A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple SclerosisA Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple SclerosisMultiple Sclerosis (MS)Drug: Ocrelizumab;Drug: rHuPH20Hoffmann-La RocheNULLActive, not recruiting18 Years65 YearsAll135Phase 1United States;Canada
220NCT04035005
(ClinicalTrials.gov)
August 12, 201917/7/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisA Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Drug: PlaceboHoffmann-La RocheNULLRecruiting18 Years65 YearsAll1000Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Colombia;Croatia;Egypt;France;Georgia;Germany;Hungary;Ireland;Italy;Mexico;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;Brazil;Netherlands
221NCT03933202
(ClinicalTrials.gov)
July 22, 201929/4/2019A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)Multiple SclerosisDrug: Cladribine TabletsEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 YearsN/AAll325United States
222NCT04022473
(ClinicalTrials.gov)
July 7, 201915/7/2019Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy VolunteersA Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female VolunteersMultiple SclerosisDrug: Bafiertam;Drug: TecfideraBanner Life Sciences LLCNULLCompleted18 Years65 YearsAll210Phase 1United States
223NCT04048577
(ClinicalTrials.gov)
July 3, 201915/4/2019A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of NatalizumabThe Impact of a Planned 12-week Dosing Interruption of Natalizumab on Immune Cell Trafficking, Pharmacokinetic (PK)/Pharmacodynamic (PD) Parameters, and Multiple Sclerosis (MS) Disease Stability.Multiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Dosing Interruption of NatalizumabBerkovich, Regina MD, PhD Inc.Biogen;Cedars-Sinai Medical CenterRecruiting21 Years65 YearsAll10Phase 4United States
224NCT03983252
(ClinicalTrials.gov)
July 201931/5/2019Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple SclerosisEffect of Alemtuzumab on Microglial Activation Assessed Using Novel [F-18]-Based Positron Emission Tomography (PET) Ligand in Multiple SclerosisMultiple SclerosisDrug: [F-18]PBR06Brigham and Women's HospitalGenzyme, a Sanofi CompanyNot yet recruiting18 Years60 YearsAll10Phase 1/Phase 2United States
225NCT03656627
(ClinicalTrials.gov)
June 27, 201931/8/2018Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbActive, not recruiting18 YearsN/AAll7Phase 1United States
226NCT03888924
(ClinicalTrials.gov)
June 17, 20194/9/2018Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)Multiple SclerosisDrug: Bacille Calmette-Guerin vaccine;Drug: PlaceboS. Andrea HospitalNULLRecruiting18 YearsN/AAll100Phase 2Italy
227NCT03995810
(ClinicalTrials.gov)
June 15, 201918/6/2019Oral Carnosine for Neuromuscular Performance in Multiple SclerosisOral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple SclerosisMultiple SclerosisDietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeksUniversity of Novi Sad, Faculty of Sport and Physical EducationCarnoMedCompleted18 Years65 YearsAll3N/ASerbia
228NCT03887065
(ClinicalTrials.gov)
June 15, 201910/3/2019Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically PatientsMagnetic Resonance Imaging 12 Day Study for Multiple Sclerosis/Clinically Isolated Syndrome Trial of JM-4 Novel Human PeptideMultiple SclerosisDrug: JM-4Cook, Stuart, MDNULLNot yet recruiting18 Years55 YearsAll15Early Phase 1NULL
229NCT03873389
(ClinicalTrials.gov)
June 12, 201912/3/2019Ocrelizumab Effects on the Metabolome in MSEvaluating the Effects of Ocrelizumab on the Circulating Metabolome in Multiple Sclerosis (MS)Multiple SclerosisDrug: OcrelizumabJohns Hopkins UniversityGenentech, Inc.Active, not recruiting18 Years75 YearsAll25United States
230NCT04056897
(ClinicalTrials.gov)
June 7, 201912/8/2019Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple SclerosisInternational Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple SclerosisMultiple SclerosisBiological: BCD-132, 125 mg;Drug: Teriflunomide;Drug: Placebo;Biological: BCD-132, 500 mgBiocadNULLActive, not recruiting18 Years60 YearsAll270Phase 2Russian Federation
231NCT03783416
(ClinicalTrials.gov)
June 1, 201910/12/2018SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple SclerosisSafety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis: A Phase 1b Randomised, Double-blind, Placebo-controlled Trial.Relapsing Remitting Multiple Sclerosis;Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: Ixazomib (NINLARO®) capsules / Matching placebo capsulesQueen Mary University of LondonTakeda Pharmaceuticals International, Inc.Not yet recruiting18 Years65 YearsAll72Phase 1United Kingdom
232NCT04203017
(ClinicalTrials.gov)
June 1, 201930/10/2019Fecal Microbiota Transplantation After Autologous HSCT in Patients With Multiple SclerosisAllogeneic Fecal Microbiota Transplantation as a Consolidation Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple SclerosisMultiple SclerosisBiological: allogeneic fecal microbiotaSt. Petersburg State Pavlov Medical UniversityNULLRecruiting18 Years55 YearsAll20Phase 1Russian Federation
233NCT03933215
(ClinicalTrials.gov)
May 21, 201929/4/2019A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Injectable DMDs for RMS (CLICK-MS)Multiple SclerosisDrug: Cladribine TabletsEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 YearsN/AAll100United States
234NCT03896217
(ClinicalTrials.gov)
May 16, 201926/10/2018Simvastatin in Secondary Progressive Multiple SclerosisA Double-blind, Randomised, Placebo-controlled Single-site Study of High Dose Simvastatin Treatment for Secondary Progressive Multiple Sclerosis: Impact on Vascular Perfusion and Oxidative DamageSecondary Progressive Multiple SclerosisDrug: SimvastatinUniversity College, LondonMS SocietyRecruiting18 Years65 YearsAll40Phase 2United Kingdom
235NCT03824938
(ClinicalTrials.gov)
April 30, 20199/1/2019Aspirin for Exercise in Multiple Sclerosis (ASPIRE)Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)Multiple SclerosisDrug: Aspirin 650mg Oral Capsule;Drug: Acetaminophen Tab 650mg;Other: PlaceboColumbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed18 Years70 YearsAll60Phase 1/Phase 2United States
236NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll312Phase 1United States;Canada
237NCT03853746
(ClinicalTrials.gov)
April 1, 201922/2/2019Short-term B-cell Depletion in Relapsing Multiple SclerosisEvaluating the Effects of Short-term B-cell Depletion on Long-term Disease Activity and Immune Tolerance in Relapsing Multiple SclerosisMultiple SclerosisDrug: OcrelizumabJohns Hopkins UniversityNational Multiple Sclerosis SocietyActive, not recruiting18 Years99 YearsAll10Phase 4United States
238NCT03710655
(ClinicalTrials.gov)
April 20196/10/2018Evaluate Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and Quality of Life in MS PatientsMulti-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and QOL in MS PatientsMultiple SclerosisDrug: Apitox - pure honeybee toxin;Drug: PlaceboApimeds, Inc.NULLUnknown status18 Years65 YearsAll468Phase 3NULL
239NCT03889639
(ClinicalTrials.gov)
March 29, 20191/3/2019Dose-finding Study for SAR442168 in Relapsing Multiple SclerosisA Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: SAR442168;Drug: Placebo;Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)SanofiNULLCompleted18 Years55 YearsAll130Phase 2United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Slovakia;Spain;Ukraine;Sweden
240NCT03856619
(ClinicalTrials.gov)
March 27, 201925/2/2019To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple SclerosisA Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: TERIFLUNOMIDE HMR1726SanofiNULLActive, not recruiting18 YearsN/AAll117Phase 4India
241NCT03283397
(ClinicalTrials.gov)
March 26, 201912/9/2017A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMSA Phase IIIb, Multi-center, International, Randomized, Assessor-blind, Active-controlled Parallel Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Neuropeptide Combination of Metenkefalin and Tridecactide (EK-12) in Comparison to Interferon Beta-1a (REBIF®) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: EK-12;Drug: INF beta-1aBosnalijek D.DMonitorCRORecruiting18 Years55 YearsAll400Phase 3Turkey
242NCT03945006
(ClinicalTrials.gov)
March 25, 20198/5/2019Balance, Trunk Impairment and Fear of Falling in Multiple Sclerosis Patients With IncontinenceAn Investigation of Balance, Trunk Impairment, and Fear of Falling in Multiple Sclerosis Patients With IncontinenceMultiple Sclerosis;Physical Therapy;IncontinenceOther: Incontinence Severity;Other: Balance;Other: Trunk impairment;Other: Fear of fallingAnkara Yildirim Beyazit UniversityNULLCompleted24 Years58 YearsAll36Turkey
243NCT03870763
(ClinicalTrials.gov)
March 19, 20197/3/2019Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric ParticipantsA Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Dimethyl Fumarate;Drug: Peginterferon Beta-1a;Drug: PlaceboBiogenNULLRecruiting10 Years17 YearsAll260Phase 3United States;Colombia;Estonia;Hungary;Jordan;Korea, Republic of;Malaysia;Mexico;Saudi Arabia;Taiwan;Thailand;Tunisia;Turkey
244NCT03799718
(ClinicalTrials.gov)
March 13, 20197/1/2019Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MSA Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MSMultiple Sclerosis, Chronic ProgressiveBiological: NurOwn (MSC-NTF cells)Brainstorm-Cell TherapeuticsNULLCompleted18 Years65 YearsAll20Phase 2United States
245NCT03737812
(ClinicalTrials.gov)
February 27, 20196/11/2018A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple SclerosisMultiple Sclerosis (MS)Drug: elezanumab;Drug: placeboAbbVieNULLCompleted18 Years65 YearsAll123Phase 2United States;Canada
246NCT03808142
(ClinicalTrials.gov)
February 20, 201910/1/2019PROmyBETAappGame: a Study to Learn More About the Medication Usage & Patient Reported Outcomes Via the myBETAapp and to Find Out More About the Usage of Game Principles and Game Design Elements (Gamification) in Medical Care of Patients With Multiple Sclerosis Treated With BetaferonPROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With BetaferonMultiple SclerosisOther: myBETAapp;Other: PEAK;Drug: Betaferon, BAY86-5046;Device: BETACONNECTBayerNULLCompleted18 YearsN/AAll79Germany
247EUCTR2017-001294-16-DE
(EUCTR)
18/02/201907/11/2018A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl FumarateA Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate Relapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR)
INN or Proposed INN: Not available
Other descriptive name: Diroximel fumarate
Trade Name: Tecfidera® 120 mg
Product Name: Tecfidera® 120 mg
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera® 240 mg
Product Name: Tecfidera® 240 mg
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Alkermes, Inc.NULLNot Recruiting Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Poland;Germany
248NCT03756974
(ClinicalTrials.gov)
February 18, 201920/11/2018BX-1 in Spasticity Due to Multiple SclerosisA Phase III, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Efficacy and Safety of BX-1 for the Symptomatic Relief of Spasticity in Patients With Multiple Sclerosis (MS)Spasticity Due to Multiple SclerosisDrug: BX-1;Drug: PlaceboBionorica SENULLCompleted18 Years65 YearsAll397Phase 3Czechia;Germany;Hungary;Poland;Spain
249NCT03752307
(ClinicalTrials.gov)
February 15, 201915/11/2018Safety and Tolerability of ISX (Isoxsuprine HCL) in MS RelapsesDouble-blind, Placebo-controlled, Randomized Study of the Safety and Tolerability of Isoxsuprine HCL Combined With High Dose Steroid Treatment of Multiple Sclerosis (MS) RelapseMultiple SclerosisDrug: Isoxsuprine Hydrochloride;Drug: Placebo;Drug: CorticosteroidUniversity of New MexicoNULLCompleted18 Years50 YearsAll2Phase 1/Phase 2United States
250NCT03623243
(ClinicalTrials.gov)
February 14, 20197/8/2018Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb StudyMultiple Sclerosis;Relapsing Multiple Sclerosis;Advancing Multiple SclerosisDrug: SiponimodNovartis PharmaceuticalsNULLRecruiting18 Years65 YearsAll400Phase 3United States;Puerto Rico
251NCT03759522
(ClinicalTrials.gov)
February 3, 20196/11/2018Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.Fibromyalgia;Chronic Fatigue Syndrome;Multiple Sclerosis;HealthyDrug: DPA-714 PET/MRIUniversity of Alabama at BirminghamNULLRecruiting18 Years65 YearsAll120Phase 1United States
252NCT03696485
(ClinicalTrials.gov)
February 1, 201930/9/2018Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMSA Prospective, Single Center, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety and Efficacy of an Intrathecal Administration of SCM-010 in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)Secondary Progressive Multiple Sclerosis (SPMS)Biological: SCM-010Stem Cell Medicine Ltd.NULLNot yet recruiting18 Years60 YearsAll12Phase 1/Phase 2Israel
253NCT03784547
(ClinicalTrials.gov)
February 1, 201913/12/2018Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAMReal-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin AmericaMultiple SclerosisDrug: OcrelizumabHospital Italiano de Buenos AiresNULLRecruitingN/AN/AAll100Argentina
254NCT03825601
(ClinicalTrials.gov)
February 1, 201921/1/2019PET With [18F]Flumazenil as an Index of Neurodegeneration in MSPET With [18F]Flumazenil as an Index of Neurodegeneration in MS: Sensitivity at an Early Disease Stage and Pathophysiological MeaningMultiple Sclerosis;Relapsing-Remitting Multiple SclerosisDiagnostic Test: PET with [11C]FlumazenilInstitut National de la Santé Et de la Recherche Médicale, FranceNULLNot yet recruiting18 Years55 YearsAll45N/ANULL
255NCT03846219
(ClinicalTrials.gov)
January 28, 201921/1/2019MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS)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 (RRMS)Drug: IMU-838 (30 mg/day);Drug: IMU-838 (45 mg/day);Drug: PlaceboImmunic AGNULLActive, not recruiting18 Years55 YearsAll210Phase 2Bulgaria;Poland;Romania;Ukraine
256NCT04595045
(ClinicalTrials.gov)
January 24, 20199/9/2020Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple SclerosisEffectiveness of Botulinum Toxin Type A Infiltrations in the Gait and Quality of Life in Adults With Spastic Lower Limb Paresis Secondary to Multiple SclerosisMultiple SclerosisDrug: Botulinum toxin type A infiltrationsAránzazu Vázquez DoceNULLActive, not recruiting18 Years80 YearsAll84Phase 3Spain
257NCT03653273
(ClinicalTrials.gov)
January 24, 201928/8/2018Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 YearsMultiple SclerosisOther: DMT withdrawal;Drug: DMT continuationRennes University HospitalNULLRecruiting50 YearsN/AAll250Phase 3France
258NCT03803800
(ClinicalTrials.gov)
January 9, 20199/1/2019Periodized Rehabilitation and Beta-alanine Supplementation in Multiple SclerosisPeriodized Rehabilitation and Beta-alanine Supplementation in Multiple SclerosisMultiple SclerosisOther: Classic, progressive endurance training;Other: Periodized exercise training;Dietary Supplement: beta-alanineHasselt UniversityNULLCompleted18 Years75 YearsAll31N/ABelgium
259EUCTR2017-005129-18-IT
(EUCTR)
08/01/201926/03/2018Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis.Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis. Relapsing-remitting multiple sclerosis with paediatric onset
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 40 mg/ml solution for injection, pre-filled syringe
INN or Proposed INN: Glatiramer Acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: AVONEX 30 µg/0,5 ml solution for injection
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Università degli Studi Aldo MoroNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Italy
260NCT03535298
(ClinicalTrials.gov)
January 3, 201914/5/2018Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMSDetermining the Effectiveness of earLy Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Early Highly Effective Therapies Group;Drug: Escalation Therapies GroupThe Cleveland ClinicUniversity of NottinghamRecruiting18 Years60 YearsAll800Phase 4United States;United Kingdom
261NCT05236777
(ClinicalTrials.gov)
January 1, 20192/2/2022TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated ParticipantsLong-term Surveillance of Patients With Multiple Sclerosis to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections Among Patients Treated With NatalizumabMultiple SclerosisDrug: NatalizumabBiogenAssociation for Functional Rehabilitation, Recreation and Applied Kinesiology ImpulseRecruitingN/AN/AAll600Czechia
262NCT04106830
(ClinicalTrials.gov)
January 1, 201925/9/2019Clinical and Imaging Patterns of Neuroinflammation Diseases in China (CLUE)Prospective Cohort Study of Clinical and Imaging Patterns of Neuroinflammation Diseases (CLUE)NMO Spectrum Disorder;MRI;Multiple SclerosisDrug: Intravenous steroidBeijing Tiantan HospitalNULLRecruiting16 Years80 YearsAll1000China
263NCT03689972
(ClinicalTrials.gov)
December 26, 201827/9/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab AdministrationMultiple Sclerosis, Relapsing-RemittingDrug: NatalizumabBiogenNULLActive, not recruiting18 Years60 YearsAll500Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom
264NCT03847545
(ClinicalTrials.gov)
December 12, 201819/12/2018Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking TechniqueMuscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle TrackingMultiple SclerosisDrug: FampridineUniversity of Southern DenmarkOdense University Hospital;Sygehus Lillebaelt;Region of Southern Denmark;The Augustinus Foundation, Denmark.;Lounkær Fonden;Fonden for scleroseramte på Fyn;The Danish Multiple Sclerosis Society;TH MAIGAARDS EFTF. FRU LILY BENTHINE LUNDS FOND AF 1. JUNI 1978;Fonden til Lægevidenskabens Fremme;Overlægeråds forskningsfondRecruiting18 Years100 YearsAll60N/ADenmark
265NCT03737851
(ClinicalTrials.gov)
December 11, 20186/11/2018A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple SclerosisMultiple Sclerosis (MS)Drug: elezanumab;Drug: placeboAbbVieNULLCompleted18 Years65 YearsAll208Phase 2United States;Canada
266NCT03944447
(ClinicalTrials.gov)
December 1, 20183/5/2019Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;CoronavirusDrug: Cannabis, Medical;Device: RYAH-Medtech InhalerOMNI Medical Services, LLCOMNI Medical Services IncRecruiting7 YearsN/AAll200000Phase 2United States
267NCT03536559
(ClinicalTrials.gov)
November 23, 20182/5/2018Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple SclerosisA Phase 2, Randomized, DB-PC, Parallel Group Study for the Treatment of Visual Pathway Deficits In Chronic Optic Neuropathy to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of CNM-Au8 For Remyelination In Multiple SclerosisRelapsing Remitting Multiple Sclerosis;Optic Neuropathy;Optic; Neuritis, With DemyelinationDrug: CNM-Au8;Drug: PlaceboClene NanomedicineClene Australia Pty LtdActive, not recruiting18 Years55 YearsAll76Phase 2United States;Australia;Canada
268NCT03650114
(ClinicalTrials.gov)
November 22, 201817/8/2018Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MSAn Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisBiological: 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-antigenNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll2010Phase 3United 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
269NCT03594487
(ClinicalTrials.gov)
November 16, 20187/6/2018Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple SclerosisFecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis: A Phase 1b Clinical Trial to Evaluate Feasibility, Safety, Tolerability and Effects on Immune FunctionRelapsing Remitting Multiple SclerosisDrug: FMP30 Donor Stool;Procedure: Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool;Other: Observational ControlJeffrey GelfandNULLActive, not recruiting18 Years60 YearsAll30Phase 1United States
270NCT03621761
(ClinicalTrials.gov)
November 15, 20183/8/2018Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis FatigueA Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple SclerosisMultiple SclerosisBehavioral: Telephone-based Cognitive Behavioral Therapy;Drug: ModafinilUniversity of MichiganUniversity of Washington;Patient-Centered Outcomes Research Institute;National Multiple Sclerosis SocietyCompleted18 YearsN/AAll336Phase 4United States
271NCT03593590
(ClinicalTrials.gov)
November 12, 201811/7/2018Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple SclerosisA Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDYMultiple SclerosisDrug: OcrelizumabHoffmann-La RocheNULLActive, not recruiting18 YearsN/AAll1700Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Dominican Republic;Egypt;Italy;Kuwait;Montenegro;Netherlands;Panama;Paraguay;Poland;Portugal;Qatar;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Turkey;United Arab Emirates;United Kingdom;Israel
272NCT03691077
(ClinicalTrials.gov)
November 11, 201828/9/2018Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714A Prospective Study Evaluating the Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in Multiple Sclerosis Using PET-MRI With 18F-DPA714Multiple Sclerosis;Relapse;Primary Progressive Multiple SclerosisDrug: OcrelizumabAssistance Publique - Hôpitaux de ParisRoche Pharma AG;Institut du Cerveau et de la Moelle épinièreRecruiting18 Years60 YearsAll51Phase 3France
273NCT04120675
(ClinicalTrials.gov)
November 9, 201824/9/2019Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple SclerosisThe Effects of Early Harvest Extra Virgin Olive Oil on Cognition and Mental Health of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis PatientsProgressive Multiple SclerosisDietary Supplement: Early Harvest Extra Virgin Olive OilAristotle University Of ThessalonikiGreek Alzheimer's Association and Related Disorders;Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com)Completed18 Years65 YearsAll30N/AGreece
274NCT03740295
(ClinicalTrials.gov)
October 5, 20185/10/2018Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple SclerosisImpact of Ketone Bodies and Epigallocatechin Gallate in Multiple SclerosisMultiple SclerosisDietary Supplement: Coconut oil and epigallocatechin gallate;Other: PlaceboFundación Universidad Católica de Valencia San Vicente MártirValencian Institute of Neurorehabilitation FoundationCompleted19 Years65 YearsAll60Phase 2Spain
275NCT03674099
(ClinicalTrials.gov)
October 1, 201814/9/2018Imatinib for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised StudyMultiple SclerosisDrug: Imatinib Mesylate;Drug: MethylprednisoloneTomas OlssonThe Swedish Research CouncilRecruiting18 Years55 YearsAll200Phase 2Denmark;Germany;Norway;Sweden
276NCT03396822
(ClinicalTrials.gov)
September 24, 20184/1/2018Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple SclerosisMeningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple SclerosisMultiple SclerosisDrug: GadoteridolUniversity of Maryland, BaltimoreGenentech, Inc.Active, not recruiting18 Years65 YearsAll24United States
277NCT03355365
(ClinicalTrials.gov)
September 21, 201814/11/2017Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple SclerosisAutologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered IntrathecallyMultiple SclerosisBiological: Intrathecal MSC-NP injection;Other: Intrathecal saline injectionTisch Multiple Sclerosis Research Center of New YorkNULLActive, not recruiting18 Years65 YearsAll50Phase 2United States
278NCT03166800
(ClinicalTrials.gov)
September 15, 201823/5/2017MitoQ for Fatigue in Multiple SclerosisMitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled TrialMultiple Sclerosis;FatigueDrug: MitoquinoneOregon Health and Science UniversityMitoQ LtdCompleted18 Years70 YearsAll9Phase 1/Phase 2United States
279NCT03606460
(ClinicalTrials.gov)
September 14, 201823/7/2018A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab Dose 1;Drug: Ocrelizumab Dose 2 and Dose 3Genentech, Inc.NULLCompleted18 Years55 YearsAll141Phase 3United States
280NCT03560739
(ClinicalTrials.gov)
September 11, 201815/5/2018A 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 PatientsA 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 PatientsMultiple SclerosisCombination Product: ofatumumab with PRF;Combination Product: ofatumumab with AINovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll284Phase 2United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain
281NCT03605238
(ClinicalTrials.gov)
August 15, 201829/6/2018Treatment of Relapsed and/or Refractory AQP4-IgG Seropositive NMOSD by Tandem CAR T Cells Targeting CD19 and CD20Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Refractory AQP4-IgG Seropositive Neuromyelitis Optica Spectrum Disorders (NMOSD)Neuromyelitis Optica Spectrum DisorderBiological: Corticosteroids & tanCART19/20Chinese PLA General HospitalNULLWithdrawn12 Years75 YearsAll0Phase 1China
282NCT03500289
(ClinicalTrials.gov)
August 10, 20184/4/2018Ketamine for Treatment of MS FatigueKetamine for Treatment of Multiple Sclerosis-related FatigueMultiple Sclerosis;FatigueDrug: Ketamine;Drug: MidazolamJohns Hopkins UniversityNational Multiple Sclerosis SocietyCompleted18 Years65 YearsAll18Phase 1/Phase 2United States
283NCT03589105
(ClinicalTrials.gov)
August 6, 20185/7/2018A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic SettingAn Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mgHoffmann-La RocheNULLCompleted18 YearsN/AAll423Phase 4France
284NCT03584672
(ClinicalTrials.gov)
August 5, 201830/6/2018The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.Multiple SclerosisOther: Static Balance Test;Other: Berg Balance Scale;Other: Timed Up an Go Test;Other: Four Square Step Test;Other: Functional Reach Test;Other: One-leg Stance TestGazi UniversityNULLUnknown status18 YearsN/AAll30NULL
285NCT04450030
(ClinicalTrials.gov)
August 1, 201824/6/2020Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple SclerosisImmunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of ActionMultiple Sclerosis, Relapsing-RemittingDrug: Methyl Prednisolonate;Procedure: ImmunoadsorptionUniversity Hospital MuensterNULLActive, not recruiting18 Years65 YearsAll204Germany
286NCT03562975
(ClinicalTrials.gov)
July 23, 201823/5/2018Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With OcrevusA Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™Multiple Sclerosis;Pathologic Processes;Demyelinating Diseases;Nervous System Diseases;Autoimmune Diseases;Immune System Diseases;Primary Progressive Multiple Sclerosis;Relapsing Remitting Multiple SclerosisDrug: OcrelizumabUniversity of South FloridaGenentech, Inc.Active, not recruiting18 Years70 YearsAll18United States
287NCT03567057
(ClinicalTrials.gov)
July 18, 201822/5/2018A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking ImpairmentA Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking ImpairmentMultiple Sclerosis;Walking ImpairmentDrug: ADS-5102, 274 mgAdamas Pharmaceuticals, Inc.NULLCompleted18 Years70 YearsAll424Phase 3United States;Canada
288NCT04881422
(ClinicalTrials.gov)
July 15, 201828/4/2021Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS ProjectSport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle ChangeMultiple SclerosisBehavioral: B-HIPE (Brief High Impact Preparatory Experience)Fondazione Don Carlo Gnocchi OnlusNULLRecruiting18 Years70 YearsAll30N/AItaly
289NCT03599245
(ClinicalTrials.gov)
July 12, 201825/6/2018This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical TrialsMultiple SclerosisDrug: OcrelizumabHoffmann-La RocheNULLRecruiting18 Years65 YearsAll1500Phase 3Argentina;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Hungary;Ireland;Italy;Kuwait;Mexico;Netherlands;Norway;Poland;Portugal;Slovakia;Slovenia;Spain;Sweden;Turkey;United Kingdom
290NCT03979456
(ClinicalTrials.gov)
July 4, 20183/6/2019RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MSRItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS. A Randomized Trial of Long-term Dosage of Rituximab in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: RituximabKarolinska InstitutetNULLActive, not recruiting20 Years52 YearsAll200Phase 3Sweden
291NCT03161028
(ClinicalTrials.gov)
July 1, 201818/5/2017Lipoic Acid for Progressive Multiple Sclerosis (MS)Lipoic Acid for the Treatment of Progressive Multiple SclerosisMultiple SclerosisDrug: Lipoic acid;Drug: PlaceboVA Office of Research and DevelopmentNULLRecruiting18 Years70 YearsAll118Phase 2United States;Canada
292EUCTR2017-001362-25-DK
(EUCTR)
27/06/201821/03/2018Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS Relapsing remitting multiple sclerosis.
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sendoxane
Product Name: Cyclophosphamide
Trade Name: Thymoglobuline®
Product Name: Thymoglobuline®
Trade Name: Lemtrada
Product Name: alemtuzumab
Trade Name: Sendoxane
Product Name: Cyclophosphamide
Trade Name: Mavenclad
Product Name: Cladribine
Trade Name: Ocrevus
Product Name: Ocrelizumab
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3Denmark;Netherlands
293NCT03369665
(ClinicalTrials.gov)
June 20, 20186/12/2017Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)Multiple SclerosisDrug: Mavenclad®Merck KGaA, Darmstadt, GermanyNULLActive, not recruiting18 YearsN/AAll485Phase 4Austria;Belgium;Czechia;Denmark;Finland;France;Greece;Hungary;Italy;Lithuania;Netherlands;Norway;Poland;Portugal;Slovakia;Spain;Sweden;United Kingdom;Germany
294NCT03423121
(ClinicalTrials.gov)
June 19, 201812/1/2018A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS PatientsA Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS PatientsProgressive Multiple SclerosisDrug: Tauroursodeoxycholic Acid;Drug: Placebo oral capsuleJohns Hopkins UniversityNULLRecruiting18 YearsN/AAll60Phase 1/Phase 2United States
295NCT03526224
(ClinicalTrials.gov)
June 14, 20183/5/2018Teriflunomide Tecfidera LMCEEffect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot StudyTecfidera;TeriflunomideDrug: Dimethyl Fumarate;Drug: TeriflunomideUniversity at BuffaloNULLCompleted18 Years65 YearsAll120United States
296NCT03493841
(ClinicalTrials.gov)
June 8, 201821/3/2018Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple SclerosisComparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover TrialMultiple Sclerosis;Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Alpha Lipoic AcidRebecca SpainNULLCompleted18 YearsN/AAll20Phase 1United States
297NCT03552211
(ClinicalTrials.gov)
May 30, 201825/4/2018Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple SclerosisEvaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: biotin;Other: propensity scoreUniversity Hospital, Clermont-FerrandOFSEP (Observatoire Français de la Sclérose en Plaques);SFSEP (Société Francophone de la Sclérose en Plaques);MedDay Pharmaceuticals SAUnknown status18 Years80 YearsAll3000France
298NCT03364036
(ClinicalTrials.gov)
May 28, 20181/12/2017Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)Multiple SclerosisDrug: Mavenclad®Merck KGaA, Darmstadt, GermanyNULLActive, not recruiting18 YearsN/AAll270Phase 4Australia;Austria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Poland;Spain;Sweden;United Kingdom;Belgium
299NCT03523858
(ClinicalTrials.gov)
May 28, 201816/4/2018A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple SclerosisAn Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple SclerosisProgressive Multiple Sclerosis (PMS)Drug: OcrelizumabHoffmann-La RocheNULLRecruiting18 Years65 YearsAll900Phase 3United States;Bosnia and Herzegovina;Brazil;Canada;Colombia;Costa Rica;Czechia;Denmark;Egypt;France;Germany;Guatemala;Hungary;Ireland;Italy;Lebanon;Mexico;Morocco;Netherlands;Panama;Poland;Russian Federation;Saudi Arabia;Spain;United Arab Emirates;Algeria
300NCT03610139
(ClinicalTrials.gov)
May 21, 201813/7/2018Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis PatientsLongitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical TrialMultiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated Syndrome;Clinically Isolated Syndrome, CNS Demyelinating;Vitamin D3 DeficiencyDietary Supplement: Vitamin D3American University of Beirut Medical CenterNULLRecruiting18 YearsN/AAll162N/ALebanon
301NCT03498131
(ClinicalTrials.gov)
May 9, 20186/4/2018Melatonin in Patients With Multiple Sclerosis (MS).Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)Relapsing Remitting Multiple SclerosisDrug: 3 mg Melatonin;Drug: 5 mg MelatoninProvidence Health & ServicesNULLActive, not recruiting18 Years65 YearsAll30Early Phase 1United States
302NCT03585569
(ClinicalTrials.gov)
May 1, 201816/3/2018 Treating MS Patients With Lower Extremity Spasticity Using DysportA Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With DysportMultiple Sclerosis;Spasticity, MuscleBiological: Abobotulinumtoxin ANeurology Center of New England P.C.IpsenUnknown statusN/AN/AAll30Phase 3United States
303EUCTR2018-000620-34-SE
(EUCTR)
24/04/201814/03/2018Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Sweden
304NCT03464448
(ClinicalTrials.gov)
April 17, 20187/3/2018Mechanistic Studies of Teriflunomide in RRMSMechanistic Studies of Teriflunomide in Relapsing Remitting Multiple Sclerosis: Regulatory B Lymphocytes as Central Mediators of the Therapeutic Effects of Teriflunomide in MSRelapsing Remitting Multiple SclerosisDrug: TeriflunomideUniversity of MichiganNULLActive, not recruiting18 Years65 YearsAll30United States
305NCT03501342
(ClinicalTrials.gov)
April 9, 201810/4/2018Effects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple SclerosisEffects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple SclerosisMultiple SclerosisOther: Virtual reality group;Other: Dynamic Balance TrainingGazi UniversityNULLCompleted18 Years65 YearsAll39N/ATurkey
306NCT04550650
(ClinicalTrials.gov)
April 6, 201810/9/2020Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS PatientsFollow-up Study of the Effectiveness of Virtual Reality Therapy in MS PatientsMultiple Sclerosis, Chronic Progressive;Multiple Sclerosis, Primary ProgressiveOther: Training groupe;Other: PNF;Other: Spinning grp;Other: BalanceSomogy Megyei Kaposi Mór Teaching HospitalNULLCompleted35 Years60 YearsAll4N/AHungary
307NCT03319732
(ClinicalTrials.gov)
April 3, 201813/10/2017A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MSAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)Multiple Sclerosis;Spasticity, MuscleDrug: ArbaclofenOsmotica Pharmaceutical US LLCNULLActive, not recruiting18 Years65 YearsAll323Phase 3United States
308NCT03850301
(ClinicalTrials.gov)
April 1, 201812/2/2019Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory TargetAn Experimental Medicine Study to Validate the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target in Multiple SclerosisMultiple SclerosisDrug: XBD173;Drug: EtifoxineImperial College LondonNULLRecruiting35 Years65 YearsAll44N/AUnited Kingdom
309NCT03436199
(ClinicalTrials.gov)
March 29, 201812/2/2018Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking ImpairmentA 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking ImpairmentWalking Impairment;Multiple SclerosisDrug: ADS-5102, 137 mg;Drug: ADS-5102, 274 mg;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted18 Years70 YearsAll558Phase 3United States;Canada
310NCT03387670
(ClinicalTrials.gov)
March 28, 201828/11/2017Multiple Sclerosis-Simvastatin Trial 2A 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 DisabilitySecondary Progressive Multiple Sclerosis (SPMS)Drug: Simvastatin;Drug: PlaceboUniversity College, LondonUniversity of Edinburgh;Queen Mary University of London;London School of Hygiene and Tropical Medicine;University of Leeds;The Leeds Teaching Hospitals NHS Trust;Imperial College Healthcare NHS TrustRecruiting25 Years65 YearsAll1180Phase 3Ireland;United Kingdom
311NCT03387046
(ClinicalTrials.gov)
March 26, 201822/12/2017A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE)Multiple Sclerosis, Relapsing-RemittingDietary Supplement: D-aspartate;Drug: Placebo;Biological: IFN beta-1a;Drug: MethylprednisoloneMerck KGaA, Darmstadt, GermanyNULLTerminated18 Years55 YearsAll7Phase 2Italy;Germany
312NCT03266965
(ClinicalTrials.gov)
March 23, 20184/7/2017Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel ApproachHistaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel ApproachMultiple SclerosisDrug: Carbidopa;Dietary Supplement: L-HistidineUniversity of MiamiUnited States Department of DefenseCompleted18 Years60 YearsAll18Phase 1United States
313NCT03477500
(ClinicalTrials.gov)
March 21, 201813/2/2018RCT Comparing Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab in MSRandomized Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab for Patients With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: Cyclophosphamide and ATG;Drug: AlemtuzumabHaukeland University HospitalNULLRecruiting18 Years50 YearsAll100Phase 3Denmark;Netherlands;Norway;Sweden
314NCT03249714
(ClinicalTrials.gov)
March 15, 201811/8/2017Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label OfatumumabA 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label OfatumumabRelapsing Multiple SclerosisDrug: Ofatumumab;Drug: Matching placebo of ofatumumabNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll64Phase 2Japan;Russian Federation
315NCT03005119
(ClinicalTrials.gov)
March 1, 201825/12/2016Evaluation of the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in MS Patients With Spasticity-related SymptomsA Phase II, Double-blind, Randomized, Placebocontrolled, Parallel-group, Single-center Study to Evaluate the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in Multiple Sclerosis (MS) Patients With Spasticity-related SymptomsMultiple SclerosisDrug: PTL201;Drug: Placebo Oral CapsulePhytoTech Therapeutics, Ltd.NULLNot yet recruiting18 Years65 YearsAll70Phase 2Israel
316NCT03551275
(ClinicalTrials.gov)
February 22, 201813/2/2018Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple SclerosisA Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisBiological: BCD-132BiocadNULLCompleted18 Years60 YearsAll24Phase 1Russian Federation
317NCT03401879
(ClinicalTrials.gov)
February 1, 201810/1/2018Retinal Neuro-vascular Coupling in Patients With Multiple SclerosisRetinal Neuro-vascular Coupling in Patients With Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Optic NeuritisDevice: Dynamic Vessel Analyzer (DVA);Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT);Device: Optical coherence tomography (OCT);Device: Optical coherence tomography angiography (OCTA)Medical University of ViennaNULLRecruiting18 YearsN/AAll50N/AAustria
318NCT03330418
(ClinicalTrials.gov)
January 29, 201831/10/2017A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum DisordersA Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders.Neuromyelitis Optica Spectrum DisordersBiological: Placebo;Biological: RC18 160 mgRemeGen Co., Ltd.NULLRecruiting18 Years65 YearsAll166Phase 3China
319NCT03290131
(ClinicalTrials.gov)
January 28, 201819/9/2017A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MSA Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple SclerosisMultiple Sclerosis;Spasticity, MuscleDrug: Arbaclofen;Drug: PlaceboOsmotica Pharmaceutical US LLCNULLCompleted18 Years65 YearsAll536Phase 3Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Moldova, Republic of;Poland;Serbia;United States
320NCT03399981
(ClinicalTrials.gov)
January 24, 20189/1/2018Tysabri Observational Cohort Study - Multiple Sclerosis (MS) RegistriesAn Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With TysabriProgressive Multifocal LeukoencephalopathyBiological: TysabriBiogenNULLActive, not recruitingN/AN/AAll72600United States
321NCT03135249
(ClinicalTrials.gov)
January 1, 201812/4/2017Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple SclerosisSequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis (SUPPRESS)Multiple Sclerosis (MS)Drug: AlemtuzumabUniversity of Texas Southwestern Medical CenterGenzyme, a Sanofi CompanyActive, not recruiting18 Years60 YearsAll40Phase 4United States
322NCT03670459
(ClinicalTrials.gov)
December 31, 20177/9/2018Forty Five Patients With Multiple Sclerosis Recieved Vestibular Rehabilitation and Balance TrainingCawthorne Cooksey Versus Vestibular Habituation Exercises on Trunk Kinetics and Velocity of Gait in Patients With Multiple SclerosisNeurologic DisorderOther: Cawthorne Cooksey exercises;Other: Vestibular habituation exercises;Other: Balance exercisesOctober 6 UniversityNULLCompleted35 Years55 YearsAll45N/AEgypt
323NCT05242133
(ClinicalTrials.gov)
December 20, 201717/1/2022Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple SclerosisEfficacy and Safety of Peginterferon Beta-1a (CinnaGen) Versus CinnoVex® (CinnaGen) in Reducing the Annualized Relapse Rate in Participants With Relapsing Remitting Multiple Sclerosis: A Phase III, Randomized, Parallel, Noninferiority StudyRelapsing Remitting Multiple Sclerosis (RRMS)Drug: Pegylated interferon beta-1a;Drug: Interferon Beta-1A Prefilled SyringeCinnagenNULLActive, not recruiting18 Years50 YearsAll168Phase 3Iran, Islamic Republic of
324NCT03385356
(ClinicalTrials.gov)
December 19, 201720/12/2017Impact of Vitamin D Supplementation in Patients With Multiple SclerosisImpact of Vitamin D Supplementation in Patients With Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Vitamin D DeficiencyDrug: Vitamin DUniversity Medical Centre MariborMedical Faculty MariborCompleted18 Years60 YearsAll89Phase 4Slovenia
325NCT03362294
(ClinicalTrials.gov)
December 11, 201715/11/2017Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMSA Prospective, Multicenter, Two Arms, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 25 mg or 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)Primary Progressive Multiple SclerosisDrug: GA Depot 40mg once monthly;Drug: GA Depot 25mg once monthlyMapi Pharma Ltd.NULLRecruiting18 Years65 YearsAll30Phase 2Israel;Moldova, Republic of
326NCT02988401
(ClinicalTrials.gov)
December 1, 20177/12/2016Intranasal Insulin for Improving Cognitive Function in Multiple SclerosisIntranasal Insulin for Improving Cognitive Function in Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary ProgressiveDrug: Insulin;Drug: Placebo (Sterile diluent)Johns Hopkins UniversityUnited States Department of DefenseCompleted18 Years70 YearsAll105Phase 1/Phase 2United States
327NCT03315923
(ClinicalTrials.gov)
December 1, 201717/10/2017Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis PatientsComparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer AcetateSecondary Progressive Multiple SclerosisDrug: Rituximab;Drug: Glatiramer AcetateIsfahan University of Medical SciencesNULLCompleted18 Years55 YearsAll84Phase 2/Phase 3Iran, Islamic Republic of
328NCT03353974
(ClinicalTrials.gov)
December 1, 201716/11/2017Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients.The Role of Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients. A Pilot Randomized Controlled Trial.Multiple SclerosisDevice: Video game therapy;Device: Balance platform therapyUniversity Hospital of FerraraNULLRecruiting18 Years60 YearsAll48N/AItaly
329EUCTR2016-003100-30-DE
(EUCTR)
29/11/201707/03/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
330NCT03347370
(ClinicalTrials.gov)
November 27, 201716/11/2017A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple SclerosisSubcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice SettingMultiple Sclerosis, Relapsing-RemittingDrug: SC Peginterferon beta-1a;Drug: SC interferon beta-1a;Drug: SC interferon beta-1bBiogenAMS Advanced Medical Services GmbHCompleted18 YearsN/AAll626Germany
331NCT03025269
(ClinicalTrials.gov)
November 15, 201716/1/2017Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple SclerosisEffect of Ocrelizumab on Gray Matter Pathology, Leptomeningeal Inflammation and Cognitive Dysfunction in Multiple SclerosisMultiple SclerosisDrug: OcrelizumabUniversity at BuffaloNULLCompleted18 Years60 YearsAll30United States
332NCT03222973
(ClinicalTrials.gov)
November 14, 201717/7/2017Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying TherapiesMultiple SclerosisDrug: BIIB033 (opicinumab);Drug: PlaceboBiogenNULLTerminated18 Years58 YearsAll263Phase 2Netherlands;Poland;Spain;Switzerland;United Kingdom;United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy
333NCT03342638
(ClinicalTrials.gov)
November 8, 20179/11/2017Maximizing Outcome of Multiple Sclerosis TransplantationMaximizing Outcome of Multiple Sclerosis Transplantation: MOST TrialMultiple Sclerosis, Relapsing-RemittingDrug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years58 YearsAll66Phase 3United States
334NCT03244696
(ClinicalTrials.gov)
November 2, 20177/8/2017Behavior and Activity Monitoring in MSBehavior and Activity Monitoring in Multiple SclerosisRelapsing-Remitting Multiple SclerosisBehavioral: Step Tracking;Behavioral: Water TrackingOhio State UniversityNational Multiple Sclerosis SocietyActive, not recruiting30 Years59 YearsAll87N/AUnited States
335NCT03350633
(ClinicalTrials.gov)
November 1, 201710/11/2017Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum DisordersSafety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 TrialNeuromyelitis Optica Spectrum Disorders;Neuromyelitis OpticaDrug: Tocilizumab Injection;Drug: AzathioprineTianjin Medical University General HospitalNULLCompleted18 YearsN/AAll118Phase 2/Phase 3China
336EUCTR2016-003100-30-GR
(EUCTR)
27/10/201721/04/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway;Sweden
337NCT03368664
(ClinicalTrials.gov)
October 24, 20172/11/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)Multiple SclerosisDrug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonistGenzyme, a Sanofi CompanyNULLActive, not recruiting10 Years17 YearsAll50Phase 3Austria;Belgium;France;Italy;Netherlands;Poland;Portugal;Russian Federation;Turkey;United Kingdom;Bulgaria;Czechia;Germany;Greece;Norway;Spain;Switzerland
338NCT03283826
(ClinicalTrials.gov)
October 19, 201713/9/2017Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple SclerosisA Phase 1/2, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisBiological: ATA188;Drug: PlaceboAtara BiotherapeuticsNULLRecruiting18 Years60 YearsAll225Phase 1/Phase 2United States;Australia
339NCT03344094
(ClinicalTrials.gov)
October 12, 201713/10/2017Mechanism of Action of Ocrelizumab in Multiple SclerosisMechanism of Action of Ocrelizumab in Multiple SclerosisMultiple Sclerosis;Immune System DiseasesDrug: ocrelizumabUniversity of ChicagoNULLRecruiting18 Years65 YearsAll30N/AUnited States
340EUCTR2016-003100-30-NO
(EUCTR)
12/10/201712/04/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden
341NCT03207464
(ClinicalTrials.gov)
October 10, 201730/6/2017Molecular Imaging of Norepinephrine Transporter (NET) Using [C-11]Methylreboxetine PET in Multiple SclerosisMolecular Imaging of Norepinephrine Transporter (NET) Using [C-11]Methylreboxetine PET in Multiple SclerosisMultiple SclerosisDrug: [C-11]MethylreboxetineBrigham and Women's HospitalNULLRecruiting18 Years60 YearsAll19Phase 1/Phase 2United States
342NCT03185065
(ClinicalTrials.gov)
October 4, 20179/6/2017Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple SclerosisTreatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple SclerosisFatigue in Multiple SclerosisDrug: Amantadine;Drug: Modafinil;Drug: Methylphenidate;Drug: PlacebosJohns Hopkins UniversityPatient-Centered Outcomes Research InstituteCompleted18 YearsN/AAll141Phase 3United States
343EUCTR2016-003100-30-NL
(EUCTR)
28/09/201711/05/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Norway;Sweden
344NCT03424733
(ClinicalTrials.gov)
September 25, 201731/1/2018Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side EffectsA Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1aMultiple SclerosisDrug: Plegridy;Drug: Prednisone;Drug: Tylenol PillHoly Name Medical Center, Inc.BiogenRecruiting18 YearsN/AAll50Phase 4United States
345NCT03122652
(ClinicalTrials.gov)
September 25, 201712/4/2017Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated SyndromeMulti-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS StudyMultiple SclerosisDrug: Teriflunomide 14 MG Oral Tablet [Aubagio];Drug: Placebo Oral TabletCentre Hospitalier Universitaire de NiceGenzyme, a Sanofi CompanyActive, not recruiting18 YearsN/AAll125Phase 3France;Switzerland;Turkey;Germany;Martinique;Sweden;United Kingdom
346NCT03326505
(ClinicalTrials.gov)
September 25, 20179/5/2017Allogenic Mesenchymal Stem Cells And Physical Therapy for MS TreatmentThe Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study.Multiple SclerosisBiological: Umbilical cord derived Mesenchymal Stem Cells;Other: Supervised physical therapyUniversity of JordanNULLCompleted18 Years65 YearsAll60Phase 1/Phase 2Jordan
347EUCTR2017-001294-16-PL
(EUCTR)
22/09/201729/06/2017A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl FumarateA Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate Relapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR)
INN or Proposed INN: Not available
Other descriptive name: Diroximel Fumarate (DRF)
Trade Name: Tecfidera® 120 mg
Product Name: Tecfidera® 120 mg
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera® 240 mg
Product Name: Tecfidera® 240 mg
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Alkermes, Inc.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Poland;Germany
348NCT03257358
(ClinicalTrials.gov)
September 19, 201718/8/2017A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg FingolimodA 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]Relapsing Multiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll382Phase 4United States
349NCT03134573
(ClinicalTrials.gov)
September 15, 201726/4/2017Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot StudyPROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot StudyMultiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY86-5046);Device: Betaconnect auto-injector;Device: myBETAappBayerNULLCompleted18 YearsN/AAll96Germany
350EUCTR2017-000559-26-IT
(EUCTR)
14/09/201730/09/2021A multicentric, international study in order to compare the effectiveness of fingolimod versus dimethyl-fumarate on patients with Multiple Sclerosis.A multicentric randomized PRAGmatic trial to compare the effectiveness of fingolimod versus dimethyl-fumarate on patient overall disease experience in relapsing remitting Multiple Sclerosis: novel data to inform decision-makers – (PRAG-MS) - PRAG-MS relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE - BLISTER DIVISIBILE PER DOSE UNITARIA(PVC/PVDC/ALU) SCATOLA DA 7X1 CAPSULE
INN or Proposed INN: FINGOLIMOD
Trade Name: TECFIDERA - 240 MG - CAPSULA RIGIDA GASTRORESISTENTE - USO ORALE - BLISTER (PVC/PE/PVDC-PVC ALLUMINIO) - 56 CAPSULE
INN or Proposed INN: DIMETIL-FUMARATO
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1360Phase 4United States;Israel;Switzerland;Italy
351NCT03282760
(ClinicalTrials.gov)
September 9, 20179/8/2017Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis PatientsA Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis PatientsSecondary-progressive Multiple SclerosisBiological: Human Neural Stem CellsCasa Sollievo della Sofferenza IRCCSAssociazione Revert ONLUS;Neurocenter of Southern Switzerland;Fondazione Cellule StaminaliCompleted18 Years60 YearsAll24Phase 1Italy;Switzerland
352EUCTR2016-003100-30-PT
(EUCTR)
28/08/201704/05/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
353NCT03183869
(ClinicalTrials.gov)
August 24, 20179/5/2017Fecal Microbial Transplantation in Relapsing Multiple Sclerosis PatientsFecal Microbial Transplantation in Relapsing Multiple Sclerosis PatientsAutoimmune Diseases;Relapsing Multiple SclerosisDrug: Fecal microbiotaLawson Health Research InstituteNULLTerminated18 YearsN/AAll14Phase 2Canada
354NCT03109288
(ClinicalTrials.gov)
August 11, 201711/4/2017Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)Multiple SclerosisDrug: Pioglitazone;Drug: clemastine fumarate;Drug: Dantrolene;Drug: PirfenidoneNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting18 YearsN/AAll250Phase 1/Phase 2United States
355NCT02744222
(ClinicalTrials.gov)
August 10, 20173/4/2016Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple SclerosisAn International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 µg and 240 µg, Versus Avonex® (Biogen Idec Ltd., UK) in Patients With Relapsing-remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: BCD-054 180 mcg;Biological: Avonex®;Biological: BCD-054 240 mcg;Other: PlaceboBiocadNULLCompleted18 Years60 YearsAll399Phase 2/Phase 3Russian Federation
356EUCTR2016-003100-30-AT
(EUCTR)
03/08/201710/08/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
357NCT03277261
(ClinicalTrials.gov)
August 1, 20177/9/2017A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS)UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)Relapsing Multiple Sclerosis (RMS)Biological: Ublituximab;Drug: TeriflunomideTG Therapeutics, Inc.NULLCompleted18 Years55 YearsAll500Phase 3United States
358NCT03277248
(ClinicalTrials.gov)
August 1, 20177/9/2017A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2)ubLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)Relapsing Multiple Sclerosis (RMS)Biological: Ublituximab;Drug: TeriflunomideTG Therapeutics, Inc.NULLCompleted18 Years55 YearsAll500Phase 3United States
359NCT03138421
(ClinicalTrials.gov)
August 1, 20171/5/2017Central Pain Study for ABX-1431A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of ABX-1431 in Patients With Central PainNeuromyelitis Optica Spectrum Disorder;Transverse Myelitis;Multiple Sclerosis;Longitudinally Extensive Transverse MyelitisDrug: ABX-1431 HCl;Drug: PlaceboAbide TherapeuticsNULLCompleted18 YearsN/AAll9Phase 1United Kingdom
360EUCTR2016-003100-30-BE
(EUCTR)
14/07/201722/05/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
361NCT02903537
(ClinicalTrials.gov)
July 6, 201721/7/2016Tolerogenic 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 ProgressiveDrug: Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3);Drug: Interferon-betaFundació Institut Germans Trias i PujolClinica Universidad de Navarra, Universidad de NavarraRecruiting18 Years60 YearsAll16Phase 1Spain
362NCT03232073
(ClinicalTrials.gov)
July 5, 201720/7/2017Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple SclerosisMulticenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: PonesimodActelionNULLActive, not recruiting18 Years65 YearsAll877Phase 3United 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
363NCT03250169
(ClinicalTrials.gov)
July 1, 201719/7/2017Neurofilaments for NEDA Assessing in MSNeurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker StudyMultiple SclerosisDrug: AlemtuzumabQueen Mary University of LondonNULLRecruiting18 Years55 YearsAll60N/AUnited Kingdom
364NCT03239860
(ClinicalTrials.gov)
June 6, 201712/7/2017Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple SclerosisA Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GNbAC1 Monoclonal AntibodyGeNeuro SALes Laboratoires Servier;Worldwide Clinical Trials;Institut de Recherches Internationales ServierTerminated18 Years55 YearsAll220Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
365EUCTR2016-003100-30-GB
(EUCTR)
05/06/201727/03/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
366NCT03381170
(ClinicalTrials.gov)
June 1, 201718/12/2017An Extension of the TG1101-RMS201 TrialAn Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple SclerosisRelapsing Remitting Multiple SclerosisBiological: UblituximabTG Therapeutics, Inc.NULLActive, not recruiting18 Years55 YearsAll48Phase 2United States
367NCT03723434
(ClinicalTrials.gov)
May 31, 201722/10/2018Physiology of Interregional Connectivity in the Human BrainPhysiology of Interregional Connectivity in the Human BrainHealthy;Stroke;Traumatic Brain Injury;Multiple SclerosisDevice: Single-pulse transcranial magnetic stimulation (spTMS);Device: Paired associative stimulation (PAS);Device: Repetitive transcranial magnetic stimulation (rTMS)Shirley Ryan AbilityLabNorthwestern UniversityUnknown status18 Years85 YearsAll76N/AUnited States
368NCT02618902
(ClinicalTrials.gov)
May 30, 201718/11/2015A NegativeDendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical TrialA NegativeDendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical TrialMultiple SclerosisBiological: tolerogenic dendritic cells (tolDC)University Hospital, AntwerpNULLActive, not recruiting18 Years60 YearsAll9Phase 1Belgium
369NCT02901106
(ClinicalTrials.gov)
May 23, 20177/9/2016Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarateMonitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEPMultiple Sclerosis, Relapsing-RemittingDrug: Dimethyl fumarateFondation Ophtalmologique Adolphe de RothschildNULLTerminated18 YearsN/AAll11Phase 4France
370NCT03126760
(ClinicalTrials.gov)
May 22, 20174/4/2017Pilot Study to Assess the Efficacy & Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple SclerosisA Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple SclerosisRelapsing, Remitting Multiple SclerosisDrug: Repository Corticotropin Injection;Drug: PlaceboMallinckrodtNULLTerminated18 YearsN/AAll35Phase 4United States
371EUCTR2016-003587-39-SE
(EUCTR)
22/05/201723/03/2017This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3700Phase 4Sweden
372NCT03269071
(ClinicalTrials.gov)
May 17, 201730/8/2017Neural Stem Cell Transplantation in Multiple Sclerosis PatientsNeural Stem Cell Transplantation in Multiple Sclerosis Patient: a Phase I StudyProgressive Multiple SclerosisDrug: human fetal-derived Neural Stem Cells (hNSCs)IRCCS San RaffaeleFondazione Italiana Sclerosi MultiplaCompleted18 Years55 YearsAll4Phase 1Italy
373EUCTR2015-005419-33-IT
(EUCTR)
09/05/201725/05/2021Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis - Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing form 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 - 100 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONE(VETRO) - 5 ML(20MG/ML) 3 FLACONI
Product Name: ofatumumab
Product Code: [OMB 157]
INN or Proposed INN: Ofatumumab
Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BISTER (ALU/ALU) PERFORATO MONODOSE - 10 X 1 COMPRESSA
Product Name: Teriflunomide
Product Code: [NA]
INN or Proposed INN: Teriflunomide
Other descriptive name: Aubagio
NOVARTIS PHARMA SERVICES AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Italy;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany
374EUCTR2015-005418-31-IT
(EUCTR)
09/05/201709/11/2020Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis - Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing form 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 - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 50 ML (20 MG/ML) 1 FLACONCINO + 2 KIT DI PROLUNGA
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BISTER (ALU/ALU) PERFORATO MONODOSE - 10 X 1 COMPRESSA
Product Name: Teriflunomide
Product Code: [NA]
INN or Proposed INN: Teriflunomide
NOVARTIS PHARMA SERVICES AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
375NCT03345940
(ClinicalTrials.gov)
April 30, 201716/5/2017Fingolimod Versus Dimethyl-fumarate in Multiple SclerosisA Multicentric Randomized PRAGmatic Trial to Compare the Effectiveness of Fingolimod Versus Dimethyl-Fumarate on Patient Overall Disease Experience in Relapsing Remitting Multiple Sclerosis: Novel Data to Inform Decision-makersRelapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Dimethyl FumarateFondazione I.R.C.C.S. Istituto Neurologico Carlo BestaPatient-Centered Outcomes Research Institute;Universita degli Studi di GenovaTerminated18 YearsN/AAll55Phase 4Italy
376NCT03073603
(ClinicalTrials.gov)
April 20, 201718/1/2017Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)Multiple SclerosisDrug: Discontinuation of disease modifying therapy;Drug: Standard of CareUniversity of Colorado, DenverPatient-Centered Outcomes Research Institute;National Multiple Sclerosis Society;University of Alabama at BirminghamCompleted55 YearsN/AAll259Phase 4United States
377NCT02881567
(ClinicalTrials.gov)
April 18, 201724/8/2016Efficacy and Safety of Daclizumab in Participants With RRMS Switching From NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)Relapsing-Remitting Multiple Sclerosis (RRMS)Drug: DaclizumabBiogenAbbVieTerminated18 Years55 YearsAll41Phase 3United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom
378EUCTR2016-003100-30-IT
(EUCTR)
11/04/201714/05/2019A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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]
Trade Name: Lemtrada
INN or Proposed INN: alemtuzumab
GENZYME CORPORATIONNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
379EUCTR2016-003100-30-ES
(EUCTR)
04/04/201722/02/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
380NCT02907177
(ClinicalTrials.gov)
March 30, 201725/8/2016Clinical 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 SclerosisDrug: Ponesimod;Other: PlaceboActelionNULLTerminated18 Years55 YearsAll136Phase 3United 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
381NCT03110315
(ClinicalTrials.gov)
March 28, 201728/3/2017A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and InsomniaA Double-blind, Crossover, Placebo-controlled Study to Compare the Effects of Nighttime Administration of Suvorexant in Patients With Multiple Sclerosis Fatigue and InsomniaMultiple Sclerosis;Fatigue;InsomniaDrug: Suvorexant;Drug: PlaceboTheodore R. Brown, MD MPHMerck Sharp & Dohme Corp.Recruiting18 Years75 YearsAll30Phase 4United States
382NCT03085810
(ClinicalTrials.gov)
March 24, 201716/3/2017Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: OcrelizumabHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll1225Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Denmark;France;Germany;Hungary;Italy;Kuwait;Lebanon;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Slovakia;Slovenia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Finland
383NCT03091400
(ClinicalTrials.gov)
March 16, 201716/3/2017Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS)Phase Two Randomized Controlled Crossover Trial of Atomoxetine to Treat Memory Impairment Due to Multiple SclerosisMemory Disorders;Multiple SclerosisDrug: Atomoxetine;Drug: PlaceboIcahn School of Medicine at Mount SinaiNULLCompleted21 Years60 YearsAll11Phase 2United States
384NCT03093324
(ClinicalTrials.gov)
March 15, 201716/3/2017A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl FumarateRelapsing Remitting Multiple SclerosisDrug: ALKS 8700;Drug: Dimethyl FumarateBiogenAlkermes, Inc.Completed18 Years65 YearsAll506Phase 3United States;Germany;Poland
385NCT05102682
(ClinicalTrials.gov)
March 10, 201725/10/2021Robotics for Mobility Rehabilitation in MSRex Robot Assisted Rehabilitation Exercise to Enhance Balance, Mobility and Upper Limb Function in People With Multiple SclerosisMultiple Sclerosis;MSOther: Balance exercise program using exoskeleton deviceEast Kent Hospitals University NHS Foundation TrustNULLCompleted18 Years90 YearsAll11Phase 1United Kingdom
386NCT03091569
(ClinicalTrials.gov)
March 10, 201721/3/2017Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With PlegridyEffects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)Relapsing-Remitting Multiple SclerosisOther: Vitamin K Cream;Other: Placebo CreamBiogenNULLCompleted18 YearsN/AAll23Phase 4Italy
387NCT02975349
(ClinicalTrials.gov)
March 7, 201723/11/2016A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.Relapsing-remitting Multiple SclerosisDrug: M2951;Drug: Placebo;Drug: TecfideraEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyActive, not recruiting18 Years65 YearsAll267Phase 2Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States
388NCT03164018
(ClinicalTrials.gov)
March 7, 201729/3/2017Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life AnalysisFampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life AnalysisMultiple SclerosisDrug: FampridineGenesis Pharma CNS & SpecialtyNULLCompleted18 YearsN/AAll111Greece
389NCT03806387
(ClinicalTrials.gov)
March 1, 20179/1/2019Physical and Cognitive Performance During the Two First Years of Lemtrada TreatmentPhysical and Cognitive Performance During the Two First Years of Lemtrada Treatment - a Prospective Observational StudyMultiple SclerosisDrug: AlemtuzumabUniversity of AarhusGenzyme, a Sanofi CompanyRecruiting18 Years65 YearsAll60Denmark
390NCT02949908
(ClinicalTrials.gov)
February 9, 201717/10/2016MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line TreatmentMultiple SclerosisDrug: RebifMerck KGaA, Darmstadt, GermanyMerck B.V., NetherlandsTerminated18 Years65 YearsAll2Phase 4Germany
391NCT03052595
(ClinicalTrials.gov)
February 1, 201710/2/2017Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR ResistanceMultiple Sclerosis: The Role of Mitochondrial Dysfunction in Insulin ResistanceMultiple Sclerosis;Mitochondrial AlterationDiagnostic Test: Oral glucose tolerance test;Diagnostic Test: Testing of autonomous nervous system function;Diagnostic Test: Stroop testSlovak Academy of SciencesComenius UniversityRecruiting18 Years45 YearsAll70Slovakia
392NCT03418376
(ClinicalTrials.gov)
February 1, 20179/1/2018Carnosine Loading and Periodized Training in MS and HCThe Impact of Carnosine Loading and Rehabilitation Therapy on Exercise Capacity in Multiple Sclerosis.Multiple Sclerosis;Exercise Therapy;Dietary SupplementDietary Supplement: Beta-alanine supplementation;Other: Exercise interventionHasselt UniversityNULLCompleted18 Years75 YearsAll45N/ABelgium
393NCT03062579
(ClinicalTrials.gov)
February 1, 201713/2/2017A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSDSingle-center, Open Label Trial of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active Neuromyelitis Optica Spectrum Disorders (NMOSD)Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica;Devic's DiseaseDrug: TocilizumabFu-Dong ShiNULLCompleted18 YearsN/AAll10Phase 1/Phase 2China
394NCT03193866
(ClinicalTrials.gov)
February 1, 201720/4/2017COMparison Between All immunoTherapies for Multiple Sclerosis.COMparison Between All immunoTherapies for Multiple Sclerosis. An Observational Long-term Prospective Cohort Study of Safety, Efficacy and Patient's Satisfaction of MS Disease Modulatory Treatments in Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: RituximabKarolinska InstitutetPatient-Centered Outcomes Research Institute;Kaiser Foundation Research InstituteActive, not recruiting18 YearsN/AAll3526Sweden
395NCT03021317
(ClinicalTrials.gov)
February 201712/1/2017Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS RelapsesEffects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS RelapsesMultiple SclerosisDrug: ACTHarUniversity of ChicagoNULLNot yet recruiting18 YearsN/AAll18Phase 4NULL
396NCT03177083
(ClinicalTrials.gov)
January 30, 201726/1/2017Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current TherapyOpen-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 SclerosisDrug: peginterferon beta-1a;Drug: interferon beta-1a;Drug: interferon beta-1bBiogenNULLCompleted18 Years65 YearsAll80Phase 4Portugal
397NCT03051646
(ClinicalTrials.gov)
January 13, 20178/2/2017Aspirin as a Pre-Treatment for Exercise in Multiple SclerosisA Placebo-controlled Double Blind Crossover Trial of Acetylsalicylic Acid as a Pre-treatment for Exercise in Multiple SclerosisFatigue;OverheatingDrug: Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit;Drug: Placebo at 1st visit, then Acetylsalicylic acid at 2nd visitColumbia UniversityNational Multiple Sclerosis SocietyCompleted18 Years60 YearsAll12Early Phase 1United States
398NCT04570670
(ClinicalTrials.gov)
January 6, 201722/9/2020Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy SubjectsA Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting ConditionsRelapsing Remitting Multiple SclerosisDrug: monomethyl fumarate 190 mg;Drug: dimethyl fumarate 240 mgBanner Life Sciences LLCNULLCompleted18 Years55 YearsAll50Phase 1NULL
399NCT03032601
(ClinicalTrials.gov)
January 5, 201719/1/2017Physiological Effects of N-Acetyl Cysteine in Patients With Multiple SclerosisPhysiological Effects of N-Acetyl Cysteine in Patients With Multiple SclerosisMultiple SclerosisDietary Supplement: N-acetyl CysteineThomas Jefferson UniversityNULLEnrolling by invitation21 Years80 YearsAll55N/AUnited States
400NCT03193086
(ClinicalTrials.gov)
January 1, 201714/6/2017The Effect of Alemtuzumab on the Blood-brain-barrier and the Brain's Metabolism in Multiple Sclerosis PatientsThe Effect of Alemtuzumab on the Blood-brain-barrier and Cerebral Metabolism in Multiple Sclerosis Patients; a New MRI Method for Treatment Response Evaluation in Multiple SclerosisMultiple SclerosisDrug: AlemtuzumabGlostrup University Hospital, CopenhagenGenzyme, a Sanofi CompanyRecruiting18 Years60 YearsAll35N/ADenmark
401NCT02980042
(ClinicalTrials.gov)
January 1, 20179/11/2016Tolerability and Safety of Switching From Rituximab to Ocrelizumab in Patients With Relapsing Forms of Multiple SclerosisEvaluating the Tolerability and Safety Profile of Switching From Rituximab to Ocrelizumab: A Real World Evaluation of Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: RituximabUniversity of Colorado, DenverNULLCompleted18 Years65 YearsAll200Phase 3United States
402NCT04719494
(ClinicalTrials.gov)
January 1, 20174/9/2020Dynamic Balance Training in Multiple SclerosisDynamic Balance Training in Multiple SclerosisMultiple SclerosisOther: Dynamic balance walking trainingMarquette UniversityGreater Milwaukee FoundationCompleted18 YearsN/AAll20N/ANULL
403NCT03172741
(ClinicalTrials.gov)
January 201725/5/2017The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple SclerosisThe Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple SclerosisMultiple SclerosisDrug: Medical Marijuana;Drug: PlaceboColorado State UniversityNULLWithdrawn21 Years74 YearsAll0Phase 2/Phase 3NULL
404NCT04082260
(ClinicalTrials.gov)
January 201728/8/2019Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment ResponseSignatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment ResponseMultiple SclerosisDrug: Alemtuzumab Injection [Lemtrada]University Hospital MuensterNULLRecruiting18 YearsN/AAll150Germany
405NCT02481882
(ClinicalTrials.gov)
January 201719/5/2015Baseline Cortical Haemodynamics in MSInvestigating Baseline Cortical Haemodynamics in Multiple SclerosisMultiple SclerosisDevice: Magnetic Resonance Imaging;Drug: Prohance (Gadoteridol)University of NottinghamNULLUnknown status21 Years80 YearsAll80N/AUnited Kingdom
406NCT02969304
(ClinicalTrials.gov)
December 30, 201621/10/2016Study of Utilization Patterns of Dimethyl Fumarate in GermanyClaims Database Study of Utilization Patterns of Dimethyl Fumarate in GermanyMultiple SclerosisDrug: dimethyl fumarateBiogenNULLCompletedN/AN/AAll930N/AGermany
407NCT03186664
(ClinicalTrials.gov)
December 28, 20167/6/2017The Role of SAtivex® in Robotic-RehabilitationThe Role of SAtivex® Associated With Robotic-Rehabilitation in Improving the Motor Performances of Multiple Sclerosis Patients (SARR)RehabilitationDevice: Lokomat training;Drug: SativexIRCCS Centro Neurolesi Bonino-PulejoNULLCompleted18 Years65 YearsAll40N/AItaly
408NCT02977533
(ClinicalTrials.gov)
December 1, 201628/11/2016A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple SclerosisA Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of GZ402668 in Men and Women With Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: GZ402668;Drug: Placebo;Drug: AcyclovirSanofiNULLCompleted18 Years65 YearsAll20Phase 1Germany
409NCT03561402
(ClinicalTrials.gov)
December 1, 20167/6/2018Biomarkers 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-RemittingDrug: TeriflunomideMcGill UniversityNULLCompleted18 Years55 YearsAll24Canada
410NCT02936037
(ClinicalTrials.gov)
December 201614/10/2016Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled StudyMultiple SclerosisDrug: MD1003 100mg capsule;Drug: PLACEBOMedDay Pharmaceuticals SANULLTerminated18 Years65 YearsAll642Phase 3United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Italy;Poland;Spain;Sweden;Turkey;United Kingdom;Czech Republic;Netherlands
411NCT02959658
(ClinicalTrials.gov)
December 20168/11/2016Dimethyl Fumarate Treatment of Primary Progressive Multiple SclerosisDimethyl Fumarate Treatment of Primary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisDrug: Dimethyl Fumarate;Drug: Placebo Oral CapsuleRigshospitalet, DenmarkBiogenActive, not recruiting18 Years65 YearsAll54Phase 2Denmark
412NCT03516526
(ClinicalTrials.gov)
November 3, 201612/4/2018Towards Personalized Dosing of Natalizumab in Multiple SclerosisTowards Personalized Dosing of Natalizumab in Multiple SclerosisMultiple SclerosisDrug: NatalizumabVU University Medical CenterSanquin Plasma Products BV;Erasmus Medical Center;St. Antonius Hospital;OLVG;Rijnstate HospitalCompleted18 YearsN/AAll61Phase 4Netherlands
413NCT02913157
(ClinicalTrials.gov)
November 201620/9/2016Hydroxychloroquine in Primary Progressive Multiple SclerosisOpen-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS)Multiple Sclerosis, Primary ProgressiveDrug: HydroxychloroquineUniversity of CalgaryNULLCompleted18 Years65 YearsAll35Phase 2Canada
414EUCTR2016-001515-20-IT
(EUCTR)
20/10/201607/02/2018ndEFFECT 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. GEMELLINULLNot RecruitingFemale: yes
Male: yes
30Phase 4Italy
415NCT02601885
(ClinicalTrials.gov)
October 18, 20165/11/2015A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple SclerosisAn Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: ABT-555;Other: PlaceboAbbVieNULLCompleted18 Years60 YearsAll20Phase 1United States
416NCT02784210
(ClinicalTrials.gov)
October 5, 201626/5/2016Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis PlaquesThe Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded StudyMultiple SclerosisDrug: Methylprednisolone;Drug: PrednisoneNational Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll30Phase 2United States
417NCT02804594
(ClinicalTrials.gov)
October 1, 20163/6/2016A Study of Oxidative Pathways in MS FatigueA Phase 2 Randomized, Placebo- Controlled, Parallel Group, Double Blinded Single Center Study on Effect of N-acetyl Cysteine Compared to Placebo on Fatigue in Patients With Progressive Multiple SclerosisProgressive Multiple Sclerosis;FatigueDrug: N-acetyl cysteine;Drug: PlaceboUniversity of California, San FranciscoNULLCompleted18 Years75 YearsAll15Phase 2United States
418NCT01649050
(ClinicalTrials.gov)
October 20166/7/2012Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple SclerosisA Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple SclerosisMuscle Spasticity Due to Multiple SclerosisDrug: BGG492;Drug: PlaceboNovartis PharmaceuticalsNULLWithdrawn18 Years65 YearsAll0Phase 2Germany;Russian Federation
419NCT02807285
(ClinicalTrials.gov)
October 201616/6/2016Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple SclerosisAn Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple SclerosisMultiple SclerosisDrug: OcrelizumabGenentech, Inc.NULLNo longer available18 Years55 YearsAllN/AUnited States
420NCT03101735
(ClinicalTrials.gov)
September 23, 20163/3/2017Study to Assess Resource Utilization and Quality of Life of Patients With RRMS Treated With Tecfidera in GreeceA Real Life, Non-interventional, Multicentre Study to Assess Resource Utilization and Quality of Life of Patients With Relapsing Forms of Multiple Sclerosis Treated With Dimethyl Fumarate in Greece - the FIDELITY StudyRRMSDrug: Dimethyl Fumarate (DMF)Genesis Pharma CNS & SpecialtyNULLCompleted18 Years65 YearsAll455Greece
421JPRN-UMIN000024312
2016/09/2025/05/2017Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosisTreatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeksTsukuba International Clinical Pharmacology ClinicNULLComplete: follow-up complete20years-old80years-oldMale and Female12Not selectedJapan
422NCT02792218
(ClinicalTrials.gov)
September 20, 20162/6/2016Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple SclerosisA Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injectionsNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll930Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Thailand;Turkey;United Kingdom
423NCT02861014
(ClinicalTrials.gov)
September 9, 20165/8/2016A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying TreatmentMultiple Sclerosis, Relapsing-RemittingBiological: OcrelizumabHoffmann-La RocheNULLCompleted18 Years55 YearsAll681Phase 3Australia;Belgium;Czechia;Denmark;Estonia;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Hong Kong
424NCT02898974
(ClinicalTrials.gov)
September 20166/9/2016Medical Marijuana and Its Effects on Motor Function in People With Multiple SclerosisMedical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis: An Observational Case-control StudyMultiple SclerosisBehavioral: Medical MarijuanaColorado State UniversityWilliam R. Shaffer, M.D.Completed30 Years60 YearsAll22United States
425NCT02792231
(ClinicalTrials.gov)
August 26, 20162/6/2016Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing 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.Relapsing Multiple ScelrosisDrug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injectionsNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll957Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Finland;France;Germany;Hungary;India;Italy;Latvia;Lithuania;Mexico;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;United Kingdom
426NCT02466074
(ClinicalTrials.gov)
August 17, 20163/6/2015Augmenting Cerebral Blood Flow to Treat Established Multiple SclerosisAugmenting Cerebral Blood Flow to Treat Established Multiple SclerosisMultiple SclerosisDrug: Acetazolamide;Drug: PlaceboThe University of Texas Health Science Center, HoustonNULLActive, not recruiting18 Years55 YearsAll60Phase 2United States
427EUCTR2015-005160-41-DE
(EUCTR)
27/07/201604/03/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Bulgaria;Russian Federation;Germany
428NCT03436927
(ClinicalTrials.gov)
July 15, 201611/12/2017Comparison of Two Different Virtual Reality Methods in Patients With Multiple SclerosisComparison of the Effects of Two Different Virtual Reality Treatment Methods in Patients With Multiple Sclerosis: A Randomized Controlled TrialMultiple SclerosisOther: Nintendo Wii Fit Balance exercises;Other: Balance Trainer Balance ExercisesBiruni UniversityIstanbul UniversityCompleted25 Years60 YearsAll51N/ANULL
429NCT02660359
(ClinicalTrials.gov)
July 8, 201614/1/2016Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2A 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 SclerosisUrinary Incontinence;Overactive BladderBiological: Botulinum toxin type A;Drug: PlaceboIpsenNULLTerminated18 Years80 YearsAll258Phase 3Argentina;Australia;Belgium;Brazil;Chile;Colombia;France;Germany;Israel;Lithuania;Mexico;Peru;Russian Federation;Spain;Ukraine;United Kingdom;New Zealand
430NCT03069170
(ClinicalTrials.gov)
July 201625/2/2017Autologous Bone Marrow Derived Stem Cells for the Treatment of Multiple Sclerosis.Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis.Multiple SclerosisBiological: Stem Cell TransplantationStem Cells ArabiaNULLRecruiting20 Years65 YearsAll50Phase 1Jordan
431NCT02921035
(ClinicalTrials.gov)
June 30, 201629/9/2016Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)A Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With RMS Who Are Prescribed Subcutaneous (sc) Interferon Beta-1a (MAIN-MS)Relapsing Multiple Sclerosis (RMS)Drug: Rebif (Interferon beta-1a)Merck KGaA, Darmstadt, GermanyMerck Serono Middle East FZ LLCCompleted18 Years60 YearsAll594Hungary;Iran, Islamic Republic of;Korea, Republic of;Kuwait;Lebanon;Morocco;Poland;Saudi Arabia;Germany;Tunisia;United Arab Emirates;Algeria;Argentina;Bahrain;Bulgaria;Egypt
432EUCTR2015-005160-41-BG
(EUCTR)
27/06/201604/05/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1 Relapsing Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700
Alkermes, Inc.NULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Russian Federation;Bulgaria;Germany
433NCT02797015
(ClinicalTrials.gov)
June 23, 201626/5/2016Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMSA Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: RPC1063CelgeneNULLCompleted18 Years55 YearsAll22Phase 1United States
434EUCTR2016-000464-42-DE
(EUCTR)
13/06/201611/04/2016The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of AlemtuzumabA Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse Relapsing-remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Other descriptive name: ALEMTUZUMAB
Genzyme GmbHNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany
435NCT02424396
(ClinicalTrials.gov)
June 13, 201620/4/2015Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple SclerosisBiological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis. Multicentric Randomized StudyRelapsing Remitting Multiple SclerosisDrug: IL2;Drug: PlaceboAssistance Publique - Hôpitaux de ParisFondation ARSEP/AFMCompleted18 Years65 YearsAll30Phase 2France
436NCT03150966
(ClinicalTrials.gov)
June 8, 20166/5/2017The Immunomodulatory Effects of Oral Nanocurcumin in Multiple Sclerosis PatientsThe Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Multiple Sclerosis PatientsMultiple SclerosisDrug: Nanocurcumin;Drug: PlaceboTabriz University of Medical SciencesNULLCompleted18 Years65 YearsAll41Phase 2Iran, Islamic Republic of
437EUCTR2015-005160-41-PL
(EUCTR)
07/06/201613/04/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1 Relapsing Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700
Alkermes, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Canada;Belgium;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany
438NCT02760056
(ClinicalTrials.gov)
June 6, 20165/4/2016Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding StudyThyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding StudyMultiple SclerosisDrug: Liothyronine sodium;Drug: PlaceboOregon Health and Science UniversityNULLCompleted18 Years50 YearsAll15Phase 1United States
439EUCTR2015-005160-41-ES
(EUCTR)
06/06/201620/04/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700
Alkermes, Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany
440NCT02870023
(ClinicalTrials.gov)
June 20169/8/2016How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?Multiple SclerosisOther: Balance training;Other: Strength trainingUniversity of AarhusVIA University College;TrygFonden, Denmark;Fondazione Don Carlo Gnocchi OnlusCompleted18 YearsN/AAll71N/ADenmark
441NCT02609607
(ClinicalTrials.gov)
June 201616/11/2015Treating Anorectal Dysfunction in MSTreating Anorectal Dysfunction Associated With Multiple SclerosisConstipation;Fecal Incontinence;Multiple SclerosisDrug: Bisacodyl;Other: PlaceboDavid LevinthalConsortium of Multiple Sclerosis CentersTerminated18 Years80 YearsAll11Phase 2United States
442NCT02446886
(ClinicalTrials.gov)
June 20167/5/2015Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MSAdrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MSMultiple SclerosisDrug: Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®)Weill Medical College of Cornell UniversityMallinckrodtCompleted18 YearsN/AAll15Phase 4United States
443NCT02676739
(ClinicalTrials.gov)
May 20, 20163/2/2016Adderall XR and Cognitive Impairment in MSA Double-blind Placebo Controlled Study of Mixed-amphetamine Salts, Extended Release (Adderall XR) for Cognitive Impairment in MSMultiple SclerosisDrug: Adderall XRSarah MorrowNULLRecruiting18 Years59 YearsAll180Phase 2/Phase 3Canada
444NCT03237832
(ClinicalTrials.gov)
May 16, 201621/7/2017A Phase 1 Study of ARN-6039A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Oral Doses of ARN-6039 in Healthy Adult Subjects.Multiple SclerosisDrug: ARN-6039;Other: PlaceboArrien PharmaceuticalsWorldwide Clinical TrialsCompleted18 Years50 YearsAll60Phase 1NULL
445NCT04633967
(ClinicalTrials.gov)
May 15, 201626/10/2020Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple SclerosisDrug: Alemtuzumab InjectionMaritime NeurologyNULLActive, not recruiting18 Years65 YearsAll30Canada
446NCT02720107
(ClinicalTrials.gov)
May 12, 201621/3/2016Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720)Relapsing-remitting Multiple SclerosisDrug: fingolimodNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll133Phase 4Germany
447NCT02649985
(ClinicalTrials.gov)
May 2, 20166/1/2016Microglial Activation Positron Emission Tomography (PET) Brain Imaging in Multiple Sclerosis and Alzheimer's DiseaseMicroglial Activation Positron Emission Tomography (PET) Brain Imaging in Multiple Sclerosis and Alzheimer's DiseaseMultiple Sclerosis;Alzheimer's DiseaseDrug: [F-18]PBR06;Drug: [C-11]PBR28Brigham and Women's HospitalNULLRecruiting18 Years85 YearsAll105Phase 1/Phase 2United States
448NCT03566251
(ClinicalTrials.gov)
May 1, 201611/6/2018Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple SclerosisThe Investigation of the Relationship Between Core Stability and Trunk Position Sense With Balance and Functional Mobility in Patients With Multiple SclerosisPhysical TherapyOther: Balance;Other: Functional mobility;Other: Core stability;Other: Trunk position senseAnkara Yildirim Beyazit UniversityNULLCompleted18 Years65 YearsAll74N/ATurkey
449NCT02746744
(ClinicalTrials.gov)
May 201618/4/2016RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. A Randomized Phase 3 Study Comparing Rituximab With Dimethyl Fumarate in Early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.Multiple Sclerosis, Relapsing-RemittingDrug: Rituximab;Drug: Dimethyl fumarate;Drug: Sodium Chloride solutionAnders SvenningssonNULLCompleted18 Years50 YearsAll200Phase 3Sweden
450NCT02670161
(ClinicalTrials.gov)
May 201623/1/2016Quality Improvement and Practice Based Research in Neurology Using the EMRQuality Improvement and Practice Based Research in Neurology Using the Electronic Medical RecordBrain Tumors;Epilepsy;Migraine;Mild Cognitive Impairment;Concussion;Multiple Sclerosis;Neuropathy;Parkinson's;Restless Legs Syndrome;StrokeDrug: Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; see Intervention Description)NorthShore University HealthSystemNULLEnrolling by invitation18 Years100 YearsAll3300Phase 4NULL
451NCT02688985
(ClinicalTrials.gov)
April 29, 201618/2/2016Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple SclerosisRelapsing Multiple Sclerorsis;Multiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: AntihistamineGenentech, Inc.NULLActive, not recruiting18 Years55 YearsAll127Phase 3United States;Canada;Germany;Sweden
452EUCTR2015-005160-41-BE
(EUCTR)
27/04/201607/03/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700
Alkermes, Inc.NULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Russian Federation;Bulgaria;Germany
453NCT02782858
(ClinicalTrials.gov)
April 201623/5/2016Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MSAn International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GNbAC1;Drug: PlaceboGeNeuro SALes Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical TrialsCompleted18 Years55 YearsAll270Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
454NCT02739542
(ClinicalTrials.gov)
March 19, 201616/3/2016Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)Multiple Sclerosis (MS)Drug: Tecfidera;Drug: PlaceboUniversity of Texas Southwestern Medical CenterBiogenCompleted18 YearsN/AAll87Phase 4United States
455NCT02738775
(ClinicalTrials.gov)
March 18, 201610/4/2016Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple SclerosisA Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis.Multiple SclerosisBiological: Ublituximab;Drug: PlaceboTG Therapeutics, Inc.NULLCompleted18 Years55 YearsAll48Phase 2United States
456EUCTR2015-004451-40-AT
(EUCTR)
01/03/201614/01/2016SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSSATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSTHE S A V A N T TRIAL - SAVANT Moderate to severe spasticity due to MS (multiple sclerosis).
MedDRA version: 19.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SATIVEX
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
INN or Proposed INN: TETRAHYDROCANNABINOL Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
Almirall Hermal GmbHNULLNot RecruitingFemale: yes
Male: yes
228Phase 4Czech Republic;Austria
457NCT02660138
(ClinicalTrials.gov)
March 201614/1/2016Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1A 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 SclerosisUrinary Incontinence;Overactive BladderBiological: Botulinum toxin type A;Drug: PlaceboIpsenNULLTerminated18 Years80 YearsAll227Phase 3United States;Canada;Czechia;Italy;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Turkey;Czech Republic;Malaysia
458NCT02555215
(ClinicalTrials.gov)
February 22, 201617/9/2015Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: dimethyl fumarateBiogenNULLCompleted10 Years17 YearsAll20Phase 3United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic
459EUCTR2015-004451-40-CZ
(EUCTR)
17/02/201622/12/2015SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSSATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSTHE S A V A N T TRIAL - SAVANT Moderate to severe spasticity due to MS (multiple sclerosis).
MedDRA version: 19.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SATIVEXAlmirall Hermal GmbHNULLNot RecruitingFemale: yes
Male: yes
228Phase 4Czech Republic;Austria
460NCT02575365
(ClinicalTrials.gov)
February 16, 201612/10/2015Effect of Fingolimod on NeurodegenerationEffect of Fingolimod on Neurodegeneration, Brain Atrophy and Cognitive Impairment in Relapsing Remitting Multiple Sclerosis PatientsCognition;Brain Volume LossDrug: 0,5 mg FingolimodNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll4Phase 4Turkey
461NCT02637856
(ClinicalTrials.gov)
February 11, 201618/12/2015A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying TreatmentMultiple Sclerosis, Relapsing-RemittingDrug: OcrelizumabGenentech, Inc.NULLCompleted18 Years55 YearsAll608Phase 3United States;Canada
462NCT02652091
(ClinicalTrials.gov)
February 5, 20165/1/2016Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient SatisfactionImpact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient SatisfactionMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1b (Betaseron, BAY86-5046);Device: BETACONNECT deviceBayerNULLCompleted18 YearsN/AAll146United States
463NCT02587065
(ClinicalTrials.gov)
February 3, 201623/10/2015Plegridy Satisfaction Study in ParticipantsMulticenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Plegridy (Pre-filled Pen) in Subjects With Relapsing-remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM)Relapsing-Remitting Multiple Sclerosis (RRMS)Drug: peginterferon beta-1aBiogenNULLCompleted18 Years65 YearsAll193Phase 4Italy
464EUCTR2015-002820-20-NL
(EUCTR)
03/02/201621/01/2016Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis?Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis? - Alpha blockers and Multiple Sclerosis (MS) Bladder dysfunction in Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10069632;Term: Bladder dysfunction;System Organ Class: 10038359 - Renal and urinary 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: SilodyxErasmus MC Dept. UrologyNULLNot RecruitingFemale: yes
Male: no
30Phase 3Netherlands
465NCT02644083
(ClinicalTrials.gov)
February 201623/12/2015Tecfidera and MRI for Brain Energy in MSModulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl FumarateMultiple SclerosisDrug: Dimethyl fumarateOregon Health and Science UniversityBiogenTerminated18 Years55 YearsAll4United States
466NCT02823951
(ClinicalTrials.gov)
February 20163/3/2016Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)Relapsing-remitting Multiple SclerosisDrug: Rebif;Drug: TecfideraIMS HEALTH GmbH & Co. OHGEMD SeronoCompleted18 Years55 YearsAll479United States;Canada
467NCT02276963
(ClinicalTrials.gov)
January 201621/10/2014Ublituximab for Acute Neuromyelitis Optica (NMO) RelapsesPhase I, Single-Center, Open Label Trial of Ublituximab + Glucocorticoids for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: UblituximabJohns Hopkins UniversityNULLCompleted18 Years100 YearsAll6Phase 1United States
468NCT02677077
(ClinicalTrials.gov)
December 31, 20153/12/2015Clinical Disease Activity With Long Term Natalizumab TreatmentMRI and Clinical Disease Activity in Patients Treated Long Term With NatalizumabRelapsing-Remitting Multiple SclerosisDrug: natalizumabBiogenNULLCompleted18 Years65 YearsAll277Belgium;Czechia;Czech Republic
469NCT02587195
(ClinicalTrials.gov)
December 18, 201522/9/2015A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension PeriodA National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension PeriodMultiple SclerosisDrug: TeriflunomideCentre Hospitalier Universitaire de NiceNULLUnknown status18 Years55 YearsAll5Phase 3France
470NCT02634307
(ClinicalTrials.gov)
December 10, 201516/12/2015A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: ALKS 8700BiogenAlkermes, Inc.Completed18 Years65 YearsAll1057Phase 3United States;Belgium;Bulgaria;Canada;Germany;Poland;Russian Federation;Serbia;Spain;Ukraine
471EUCTR2013-001151-12-HR
(EUCTR)
08/12/201501/02/2016EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Relapsing Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United States;Saudi Arabia;Taiwan;Hong Kong;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Romania;Croatia;Germany;Japan;Sweden
472EUCTR2013-001150-10-HR
(EUCTR)
07/12/201501/02/2016STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA 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
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000167619;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden
473NCT02583594
(ClinicalTrials.gov)
December 6, 201516/10/2015A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple SclerosisA Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: DexchlorpheniramineGenzyme, a Sanofi CompanyNULLCompleted18 YearsN/AAll24Phase 1Spain
474NCT02545959
(ClinicalTrials.gov)
November 30, 20157/9/2015Intrathecal Rituximab in Progressive Multiple SclerosisIntrathecal Rituximab in Progressive Multiple SclerosisMultiple Sclerosis, Chronic Progressive;Nervous System DiseasesDrug: Rituximab IT;Drug: methylprednisolone IV;Drug: Rituximab IVCentre Hospitalier de PAUUniversity Hospital, BordeauxCompleted45 YearsN/AAll10Phase 2France
475NCT02511028
(ClinicalTrials.gov)
November 27, 201528/7/2015In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance ImagingIn Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance ImagingMultiple SclerosisDrug: FerumoxytolNational Institute of Neurological Disorders and Stroke (NINDS)National Institutes of Health Clinical Center (CC)Completed18 Years70 YearsAll14Phase 1United States
476JPRN-JapicCTI-153058
24/11/201504/11/2015Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple SclerosisCopaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple Sclerosis Multiple sclerosisIntervention name : Copaxone subcutaneous injection syringe
Dosage And administration of the intervention : For adults, a 20 mg dose of glatiramer acetate will be subcutaneously administered once daily.Participants will receive interventions as part of routine medical care.
TAKEDA PHARMACEUTICAL COMPANY LTD.NULLrecruitingBOTH1000NANULL
477NCT03209479
(ClinicalTrials.gov)
November 24, 20154/7/2017Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple SclerosisCopaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple SclerosisMultiple SclerosisDrug: Glatiramer acetateTakedaNULLRecruitingN/AN/AAll1000Japan
478NCT02471560
(ClinicalTrials.gov)
November 6, 201511/6/2015Tecfidera and the Gut MicrobiotaThe Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events.Multiple Sclerosis, Relapsing-RemittingDrug: dimethyl fumarate;Drug: injectable MS DMTBiogenNULLCompleted18 YearsN/AAll36Phase 4Norway
479NCT02490982
(ClinicalTrials.gov)
November 201526/6/2015Teriflunomide Observational Effectiveness StudyTeriflunomide Observational Effectiveness StudyRelapsing Remitting Multiple SclerosisDrug: TeriflunomideCentre hospitalier de l'Université de Montréal (CHUM)Genzyme, a Sanofi Company;Montreal Neurological Institute and HospitalCompleted18 YearsN/AAll106Canada
480NCT02545868
(ClinicalTrials.gov)
October 27, 20158/9/2015A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple SclerosisA Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: 23-PPV;Biological: 13-PCV Booster;Biological: Influenza Vaccine;Biological: KLH;Drug: OCR;Biological: TT VaccineHoffmann-La RocheNULLCompleted18 Years55 YearsAll102Phase 3United States;Canada
481NCT02576717
(ClinicalTrials.gov)
October 16, 201528/9/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis PatientsMultiple SclerosisDrug: RPC1063CelgeneNULLActive, not recruiting18 Years55 YearsAll2495Phase 3United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Germany;Greece;Hungary;Italy;Latvia;Lithuania;Moldova, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Ukraine;United Kingdom
482NCT02529839
(ClinicalTrials.gov)
October 201510/6/2015Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple SclerosisMultiple SclerosisProcedure: Autologous bone marrow transplantation;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: AlemtuzumabHadassah Medical OrganizationNULLNot yet recruiting18 Years65 YearsBoth20N/ANULL
483NCT02606630
(ClinicalTrials.gov)
October 201513/11/2015[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple SclerosisA [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 SclerosisMultiple SclerosisDrug: ABT-555AbbVieNULLTerminated18 Years60 YearsAll4Phase 1United Kingdom
484NCT02410200
(ClinicalTrials.gov)
September 30, 20152/4/2015Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMSOpen-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 YearsMultiple Sclerosis, Relapsing-RemittingDrug: dimethyl fumarateBiogenNULLCompleted10 Years17 YearsAll22Phase 2United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic
485NCT02486640
(ClinicalTrials.gov)
September 8, 201515/6/2015Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With BetaferonBETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment AdherenceMultiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY86-5046);Device: Betaconnect AutoinjectorBayerNULLCompleted18 YearsN/AAll162Germany
486NCT03774914
(ClinicalTrials.gov)
September 1, 201511/12/2018LEMTRADA Pregnancy Registry in Multiple SclerosisInternational LEMTRADA Pregnancy Exposure Cohort in Multiple SclerosisMultiple SclerosisDrug: Alemtuzumab (GZ402673)Genzyme, a Sanofi CompanyNULLActive, not recruiting18 Years55 YearsFemale204Austria;Germany;Italy;United Kingdom;Belgium;Canada;Denmark;Spain;Sweden;United States
487NCT03002038
(ClinicalTrials.gov)
September 201521/12/2016Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD PatientsComparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum DisordersNeuromyelitis Optica Spectrum DisorderDrug: Azathioprine;Drug: RituximabIsfahan University of Medical SciencesNULLCompleted18 Years50 YearsAll86Phase 2/Phase 3Iran, Islamic Republic of
488NCT02283671
(ClinicalTrials.gov)
September 201529/10/2014Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 BMultiple Sclerosis;Neuromyelitis OpticaBiological: Tolerogenic Dendritic cells loaded with myelin peptidesSara VareaNULLCompleted18 Years65 YearsAll20Phase 1Spain
489NCT02525874
(ClinicalTrials.gov)
August 11, 201510/7/2015Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple SclerosisDrug: dimethyl fumarateBiogenNULLCompleted18 Years65 YearsAll218Phase 3United States;Belgium;Bulgaria;Kuwait;Lithuania;Poland;Turkey;Croatia
490NCT02499900
(ClinicalTrials.gov)
August 10, 20151/7/2015CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL DailyCONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL DailyMultiple SclerosisDrug: Copaxone®Teva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 YearsN/AAll861Phase 4United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey
491NCT02493049
(ClinicalTrials.gov)
August 20152/7/2015Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis (RRMS)Randomized, Controlled Pilot Trial of Domperidone in Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: DomperidoneUniversity of CalgaryAlberta Innovates Health SolutionsCompleted18 Years60 YearsAll17Phase 2Canada
492NCT02542787
(ClinicalTrials.gov)
August 20154/9/2015Study of VSN16R for the Treatment of Spasticity in Multiple SclerosisA 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 SclerosisSpasticity in People With Multiple SclerosisDrug: VSN16R;Other: PlaceboCanbex Therapeutics LtdNULLCompleted18 Years70 YearsAll160Phase 2United Kingdom
493NCT02683863
(ClinicalTrials.gov)
August 201514/1/2016Pharmacokinetics of DMF and the Effects of DMF on Exploratory BiomarkersAn Open Label Study of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple SclerosisMultiple SclerosisDrug: BG00012 (DMF) (Tecfidera®.)Multiple Sclerosis Center of Northeastern New YorkBiogenCompleted25 Years65 YearsAll20Phase 4United States
494NCT02686788
(ClinicalTrials.gov)
August 201514/10/2015TMP001 in Relapsing-remitting Multiple SclerosisTMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical TrialRemitting-Relapsing Multiple SclerosisDrug: TMP001Dr. Frank BehrensSocraMetrics GmbHCompleted18 Years55 YearsAll9Phase 2Germany
495NCT02665221
(ClinicalTrials.gov)
July 201522/1/2016Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDYSingle Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size.Multiple SclerosisOther: No Treatment Arm;Drug: Topical Preparation H armNew York University School of MedicineNULLTerminated18 Years70 YearsAll32Phase 4United States
496NCT02506751
(ClinicalTrials.gov)
July 201512/7/2015Open-label Study of Liothyronine in MSA Phase 1b, Open-label Study to Evaluate the Safety and Tolerability of the Putative Remyelinating Agent, Liothyronine, in Individuals With MSMultiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary ProgressiveDrug: liothyronineJohns Hopkins UniversityNULLCompleted18 Years58 YearsAll20Phase 1United States
497NCT02425644
(ClinicalTrials.gov)
June 4, 201521/4/2015Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple SclerosisMulticenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: ponesimod;Drug: teriflunomideActelionNULLCompleted18 Years55 YearsAll1133Phase 3United 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
498NCT02419378
(ClinicalTrials.gov)
June 201531/3/2015Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective PotentialAlemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective PotentialMultiple Sclerosis, Relapsing-RemittingDrug: AlemtuzumabUniversity Hospital MuensterGenzyme, a Sanofi CompanyCompleted18 Years55 YearsAll15Phase 4Germany
499NCT02239393
(ClinicalTrials.gov)
June 201510/9/2014Safety and Efficacy of Intravenous Autologous Mesenchymal Stem Cells for MS: a Phase 2 Proof of Concept StudyMEsenchymal Stem Cell Therapy for CAnadian MS PatientsMultiple SclerosisBiological: Mesenchymal Stem CellsOttawa Hospital Research InstituteNULLCompleted18 Years50 YearsAll31Phase 2Canada
500NCT03113162
(ClinicalTrials.gov)
May 29, 201510/4/2017Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) for Multiple SclerosisEvaluation of the Safety and Efficacy of Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) in Multiple SclerosisMultiple SclerosisBiological: Autologous Hematopoietic Stem Cell;Drug: BEAM RegimenMakati Medical CenterNULLRecruiting18 Years60 YearsAll15Phase 1Philippines
501NCT02315872
(ClinicalTrials.gov)
May 22, 20159/12/2014ACTH for Fatigue in Multiple Sclerosis PatientsThe Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.Multiple Sclerosis, Relapsing-RemittingDrug: ACTH;Drug: PlaceboProvidence Health & ServicesMallinckrodtCompleted18 Years65 YearsAll8Phase 3United States
502NCT02495766
(ClinicalTrials.gov)
May 11, 20153/6/2015Autologous Mesenchymal Stromal Cells for Multiple SclerosisTreatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: XCEL-MC-ALPHA;Drug: PlaceboBanc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)Completed18 Years60 YearsAll8Phase 1/Phase 2Spain
503NCT02461069
(ClinicalTrials.gov)
May 6, 201527/5/2015Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple SclerosisA 24-week, Multicenter, Exploratory, Two Arm Study to Assess the Effect of Dimethyl Fumarate on Immune-Modulatory Action on T Cells in Patients With Relapsing Remitting Multiple Sclerosis (DIMAT-MS)Multiple Sclerosis, Relapsing-RemittingDrug: Dimethyl fumarateUniversity Hospital MuensterBiogenCompleted18 Years60 YearsAll67Phase 4Germany
504NCT02430532
(ClinicalTrials.gov)
May 201527/4/2015BG00012 and Delay of Disability Progression in Secondary Progressive Multiple SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple SclerosisMultiple Sclerosis, Secondary ProgressiveDrug: dimethyl fumarate;Other: PlaceboBiogenNULLTerminated18 Years58 YearsAll58Phase 3United States;Belgium;Czech Republic;Netherlands;Poland;Slovakia;Austria;Sweden
505NCT02471222
(ClinicalTrials.gov)
May 201511/6/2015Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking ImpairmentSafety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking ImpairmentWalking Impairment;Multiple SclerosisDrug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted18 Years70 YearsAll60Phase 2United States
506EUCTR2013-003884-71-DK
(EUCTR)
30/04/201524/02/2015Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ 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
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1248Phase 3;Phase 4United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Germany;Netherlands;Sweden
507EUCTR2013-001150-10-CZ
(EUCTR)
22/04/201519/09/2014STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT Neuromyelitis optica
MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Martinique;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden
508EUCTR2013-001151-12-CZ
(EUCTR)
22/04/201519/09/2014EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;United Arab Emirates;Saudi Arabia;Thailand;Spain;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden;Martinique;Hong Kong;Taiwan
509NCT02423083
(ClinicalTrials.gov)
April 21, 201521/4/2015Oral Guanabenz for Multiple SclerosisPhase I Study of Oral Guanabenz for Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple SclerosisDrug: GuanabenzNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 Years55 YearsAll2Phase 1United States
510NCT04928313
(ClinicalTrials.gov)
April 12, 201514/4/2021Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in IranA Phase IV, Post-marketing, Prospective, Multicenter Study to Investigate the Safety and Effectiveness of Cinnomer® (Glatiramer-Acetate) in Multiple Sclerosis (MS) Treatment in IranRelapsing Multiple SclerosisDrug: Glatiramer AcetateCinnagenNULLCompleted18 Years60 YearsAll368Phase 4NULL
511NCT02200770
(ClinicalTrials.gov)
April 1, 201516/7/2014N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum DisordersA Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersNeuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersDrug: Inebilizumab;Other: PlaceboMedImmune LLCNULLCompleted18 YearsN/AAll231Phase 2/Phase 3United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;Mexico;Moldova, Republic of;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Turkey;China;Czech Republic;Greece;India;Netherlands;Portugal;Ukraine
512NCT02391961
(ClinicalTrials.gov)
April 1, 20153/3/2015Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple SclerosisStudy and Treatment of Visual Dysfunction and Motor Fatigue in Multiple SclerosisMultiple Sclerosis;Internuclear Ophthalmoplegia;FatigueDrug: Dalfampridine;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years65 YearsAll23Phase 2United States
513NCT02428231
(ClinicalTrials.gov)
April 201523/4/2015Tecfidera Slow-Titration StudyA Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple SclerosisMultiple SclerosisDrug: dimethyl fumarateBiogenNULLTerminated18 Years65 YearsAll62Phase 3United States;Belgium;Czech Republic;Italy;Australia;Canada;France;Germany;Hungary;Spain
514NCT02939079
(ClinicalTrials.gov)
April 201514/10/2016Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis PatientsEvaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-a , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: Fingolimod;Dietary Supplement: Fish Oil;Drug: Placebo (for Fish Oil)Isfahan University of Medical SciencesShiraz University of Medical SciencesCompleted18 Years45 YearsAll50Phase 2/Phase 3NULL
515NCT02398461
(ClinicalTrials.gov)
April 201513/3/2015An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a RelapseA Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a RelapseMultiple Sclerosis, Acute RelapsingDrug: rHIgM22;Drug: PlaceboAcorda TherapeuticsPRA Health SciencesCompleted18 Years70 YearsAll27Phase 1United States
516NCT02373098
(ClinicalTrials.gov)
March 31, 20154/2/2015Fingolimod Effect on Cytokine and Chemokine LevelsEffects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDrug: Fingolimod 0.5 mgNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll126Phase 4Turkey
517EUCTR2013-001151-12-DK
(EUCTR)
25/03/201511/02/2015EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hong Kong;Taiwan;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Singapore;Croatia;Romania;Germany;Japan;Sweden
518NCT02386566
(ClinicalTrials.gov)
March 20, 20156/2/2015Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With NatalizumabA Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With NatalizumabMultiple SclerosisDrug: natalizumabBiogenNULLCompleted18 Years65 YearsAll48Switzerland
519EUCTR2014-003145-99-GB
(EUCTR)
19/03/201519/01/2015A trial to determine bexarotene's safety and tolerability and it's ability to promote brain repair in patients with multiple sclerosis.A randomised placebo-controlled study of the safety and tolerability of a retinoid-X receptor agonist's ability to promote remyelination in people with relapsing-remitting multiple sclerosis already on interferon-beta therapy: a phase 2a trial - CCMR One Relapsing-remitting multiple sclerosis already on interferon-beta therapy
MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targretin
Product Name: Bexarotene
INN or Proposed INN: Bexarotene
Cambridge University Hospitals NHS Foundation Trust and the University of CambridgeNULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom
520NCT02410278
(ClinicalTrials.gov)
March 12, 20152/4/2015Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving TecfideraA Multicenter, Double- Blind, Placebo- Controlled Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera® (Dimethyl Fumarate) Delayed Release CapsulesMultiple SclerosisDrug: dimethyl fumarate;Drug: montelukast;Drug: PlaceboBiogenNULLCompleted18 YearsN/AAll102Phase 4United States
521EUCTR2013-001150-10-DK
(EUCTR)
06/03/201511/02/2015STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT neuromyelitis optica
MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Martinique;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden
522NCT02343159
(ClinicalTrials.gov)
February 28, 20159/1/2015Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients.Multiple SclerosisDrug: dimethyl fumarate;Device: Medication Event Monitoring System (MEMS);Behavioral: Adherence counselingBiogenNULLTerminated18 Years65 YearsAll84Phase 4United States
523NCT02097849
(ClinicalTrials.gov)
February 28, 201525/3/2014Vaccination 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 SclerosisDrug: dimethyl fumarate;Biological: tetanus diphtheria toxoids vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent);Drug: non-pegylated interferonBiogenNULLCompleted18 Years55 YearsAll71Phase 2United States
524EUCTR2009-010788-18-PL
(EUCTR)
17/02/201518/08/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study Relapsing Remitting 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: Alemtuzumab
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United States;Serbia;Spain;Ukraine;Austria;Israel;Sweden;Germany;Netherlands;Australia;Denmark;Croatia;Brazil;Poland;Belgium;Argentina;Canada;Mexico;Czech Republic;United Kingdom;Italy;Russian Federation
525NCT02335450
(ClinicalTrials.gov)
February 12, 20157/1/2015Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case SeriesTheory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case SeriesMultiple SclerosisBehavioral: Motivational Interviewing;Device: Wristband physical activity monitorOakland UniversityNULLCompleted19 YearsN/AAll5N/AUnited States
526EUCTR2013-003884-71-BE
(EUCTR)
05/02/201504/08/2014Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ Relapsing-remitting multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
799Phase 3Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
527EUCTR2013-003884-71-NL
(EUCTR)
02/02/201511/08/2014Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ 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: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1248Phase 3;Phase 4Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Denmark;Australia;Germany;Netherlands;Sweden
528NCT02587715
(ClinicalTrials.gov)
February 201526/10/2015A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMSAn Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingBiological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapyNovo Cellular Medicine Institute LLPNULLRecruiting18 Years60 YearsBoth69Phase 1/Phase 2Trinidad and Tobago
529NCT03092544
(ClinicalTrials.gov)
February 201523/6/2016Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive PatientsInvestigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive PatientsMultiple SclerosisDrug: dimethyl fumarateMultiple Sclerosis Center of Northeastern New YorkIcahn School of Medicine at Mount Sinai;BiogenUnknown status18 Years65 YearsAll57Phase 4United States
530NCT02418325
(ClinicalTrials.gov)
February 20158/4/2015A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMSAn Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingBiological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapyGenesis LimitedNULLTerminated18 Years60 YearsBoth69Phase 1/Phase 2Trinidad and Tobago
531NCT02403947
(ClinicalTrials.gov)
February 20159/3/2015MEsenchymal StEm Cells for Multiple SclerosisTreatment of Multiple Sclerosis With Mesenchymal Stem Cells: Phase I/II StudyMultiple SclerosisDrug: Mesenchymal stem cells;Drug: Suspension mediaUniversity Hospital, ToulouseNULLTerminated18 Years50 YearsAll1Phase 1/Phase 2France
532NCT02308137
(ClinicalTrials.gov)
February 20152/12/2014Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Domperidone 10mg QID for Reducing Progression of Disability in Patients With Secondary Progressive Multiple Sclerosis (SPMS)Multiple Sclerosis, Secondary ProgressiveDrug: DomperidoneUniversity of CalgaryAlberta Innovates Health SolutionsCompleted18 Years60 YearsAll64Phase 2Canada
533NCT02638038
(ClinicalTrials.gov)
February 201516/12/2015This 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 YearsA 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 SclerosisMultiple Sclerosis, Relapsing RemittingDrug: INT131InteKrin Therapeutics, Inc.NULLCompleted18 Years50 YearsAll228Phase 2NULL
534NCT02166021
(ClinicalTrials.gov)
January 29, 201520/5/2014Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple SclerosisPhase 2 Trial to Investigate the Clinical Efficacy & the Optimal Administration (Based on the Immunological, Clinical & Neuroradiological Effects) of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple SclerosisMultiple Sclerosis (MS)Biological: Mesenchymal stem cellsDimitrios KarussisNULLCompleted18 Years65 YearsAll48Phase 2Israel
535NCT02284568
(ClinicalTrials.gov)
January 12, 201531/10/2014A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to PlaceboA Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS)Primary Progressive Multiple SclerosisDrug: Placebo;Drug: LaquinimodTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted25 Years55 YearsAll374Phase 2United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
536NCT02255656
(ClinicalTrials.gov)
January 7, 201530/9/2014Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)Relapsing Remitting Multiple SclerosisDrug: alemtuzumab GZ402673Genzyme, a Sanofi CompanyNULLActive, not recruiting18 YearsN/AAll812Phase 4United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Spain;Sweden;Ukraine;United Kingdom;Czech Republic
537NCT02427776
(ClinicalTrials.gov)
January 20152/4/2015A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple SclerosisA Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimulated and Expanded ex Vivo by a Myelin Oligodendrocyte Glycoprotein Peptide Modified by the Introduction of a Thioreductase Motif Into the Flanking Residues of the Cell Epitope - A First-in-human Trial (SCLEROLYM TRIAL)Multiple Sclerosis, Relapsing-RemittingBiological: 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 epitopeImcyse SANULLTerminated18 Years50 YearsAll2Phase 1/Phase 2Belgium
538NCT02003144
(ClinicalTrials.gov)
January 201518/11/2013An Open Label Extension Trial of Eculizumab in Relapsing NMO PatientsA Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderBiological: eculizumabAlexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll119Phase 3United States;Argentina;Australia;Canada;Colombia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;France;Singapore
539NCT02254304
(ClinicalTrials.gov)
December 31, 201429/9/2014Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania Using Electronic Device RebiSmart™Relapsing Multiple Sclerosis;Clinically Isolated SyndromeDrug: RebifMerck KGaA, Darmstadt, GermanyMerck Romania SRL, an affiliate of Merck KGaA, Darmstadt, GermanyCompleted18 Years65 YearsAll106Phase 4Germany
540EUCTR2013-003884-71-HR
(EUCTR)
30/12/201430/03/2015Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ 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: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
799Phase 3;Phase 4Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden;United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom
541EUCTR2013-003884-71-DE
(EUCTR)
23/12/201427/10/2014Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ 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: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1248Phase 3;Phase 4United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden
542EUCTR2013-003884-71-IT
(EUCTR)
22/12/201428/10/2014Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ Relapsing-remitting 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]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
799Phase 3;Phase 4Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
543EUCTR2014-000709-10-DE
(EUCTR)
19/12/201413/10/2014Investigation 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 MünsterNULLNot RecruitingFemale: yes
Male: yes
15Phase 4Germany
544NCT01910259
(ClinicalTrials.gov)
December 18, 201419/7/2013MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation TrialA Multi-arm Phase IIB Randomised, Double Blind Placebo-controlled Clinical Trial Comparing the Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis.Secondary Progressive Multiple SclerosisDrug: Amiloride;Drug: Riluzole;Drug: Fluoxetine;Drug: PlaceboUniversity College, LondonMedical Research Council;National Institute for Health Research, United Kingdom;MS Society;University of Edinburgh;Queen Mary University of London;Keele University;University of Sheffield;University of Leeds;University of WarwickCompleted25 Years65 YearsAll445Phase 2United Kingdom
545NCT02294058
(ClinicalTrials.gov)
December 3, 20145/8/2014Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis PatientsMultiple SclerosisDrug: Ozanimod;Drug: Interferon beta-1a;Drug: Placebo to ozanimod;Drug: Placebo to interferon beta-1aCelgeneNULLCompleted18 Years55 YearsAll1346Phase 3United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Latvia;Lithuania;Moldova, Republic of;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Argentina;Austria;Colombia;Czech Republic;Mexico;Peru
546EUCTR2013-003884-71-ES
(EUCTR)
01/12/201403/10/2014Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ Relapsing-remitting multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
799Phase 3Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
547NCT02087631
(ClinicalTrials.gov)
December 201412/3/2014Safety and Tolerability of Quetiapine in Multiple SclerosisA Dose-finding, Safety and Tolerability Trial of Extended-release Quetiapine in Relapsing-remitting and Progressive Multiple SclerosisMultiple SclerosisDrug: Extended-release quetiapine fumarateUniversity of CalgaryMultiple Sclerosis Society of CanadaCompleted18 Years65 YearsAll14Phase 1/Phase 2Canada
548NCT02342704
(ClinicalTrials.gov)
November 30, 201415/1/2015Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) ParticipantsA Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis SubjectsRelapsing-Remitting Multiple SclerosisDrug: natalizumab;Drug: fingolimodBiogenNULLTerminated18 Years60 YearsAll111Phase 4United States;Australia;Czechia;France;Germany;Italy;Spain;Sweden;United Kingdom;Czech Republic;Denmark
549NCT02230969
(ClinicalTrials.gov)
November 12, 201429/8/2014Plegridy Observational ProgramPlegridy™ (Peginterferon ß-1a) Real World Effectiveness and Safety Observational ProgramRelapsing Forms of Multiple SclerosisDrug: peginterferon beta-1aBiogenNULLCompleted18 YearsN/AAll1208United States;Australia;Austria;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom
550NCT02253264
(ClinicalTrials.gov)
November 201429/9/2014A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis PatientsA Phase 1 Open-label Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients With Magnetic Resonance Imaging Evidence of Leptomeningeal EnhancementPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: RituximabJohns Hopkins UniversityNULLCompleted18 YearsN/AAll8Phase 1United States
551NCT02326935
(ClinicalTrials.gov)
November 201418/12/2014Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple SclerosisProposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple SclerosisMultiple SclerosisBiological: Autologous adipose derived mesenchymal cellsAmerican CryoStem CorporationNULLTerminated18 Years65 YearsAll2Phase 1Cayman Islands
552NCT02247310
(ClinicalTrials.gov)
October 20, 201419/9/2014BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With BetaferonBETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®Multiple Sclerosis, Relapsing RemittingDrug: Interferon beta-1b (Betaferon®, BAY 86-5046);Device: BETACONNECTBayerNULLCompletedN/AN/AAll498N/AAustria;Belgium;Bosnia and Herzegovina;Croatia;Czechia;France;Greece;Hungary;Italy;Spain;Switzerland;Czech Republic;Netherlands
553EUCTR2013-003884-71-CZ
(EUCTR)
06/10/201411/08/2014Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ 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: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1248Phase 3;Phase 4United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden
554NCT02212886
(ClinicalTrials.gov)
October 20145/8/2014Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMSA Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: GA Depot 80 mg;Drug: GA Depot 40 mgMapi Pharma Ltd.NULLActive, not recruiting18 Years70 YearsAll25Phase 1/Phase 2Israel
555NCT02228213
(ClinicalTrials.gov)
October 201421/8/2014Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple SclerosisA Phase 2B Randomised, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of MIS416 in the Treatment of Subjects With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisBiological: MIS416;Drug: SalineInnate ImmunotherapeuticsINC ResearchCompleted18 Years70 YearsAll93Phase 2Australia;New Zealand
556NCT02296346
(ClinicalTrials.gov)
October 201418/11/2014Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple SclerosisA Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS)Secondary Progressive Multiple SclerosisDrug: SoluMedrol;Device: Extracorporeal PhotopheresisUniversity of UtahMallinckrodtTerminated18 Years75 YearsAll13N/AUnited States
557NCT02280096
(ClinicalTrials.gov)
October 201410/10/2014Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple SclerosisEfficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis. Randomized, Blinded, Placebo-controlled Clinical Trial.Multiple SclerosisDrug: 4-aminopyridine;Drug: PlaceboCoordinación de Investigación en Salud, MexicoNULLCompleted18 Years60 YearsAll24Phase 2Mexico
558NCT02104661
(ClinicalTrials.gov)
October 20141/4/2014Protective Role of Oxcarbazepine in Multiple SclerosisOxCarbazepine as a Neuroprotective Agent in MS: A Phase 2a TrialMultiple SclerosisDrug: Oxcarbazepine;Drug: PlaceboQueen Mary University of LondonNational Multiple Sclerosis Society;Novartis Pharmaceuticals;Barts & The London NHS Trust;University College, London;Royal Free Hospital NHS Foundation Trust;Southend University Hospital;Basildon and Thurrock University Hospitals NHS Foundation Trust;St George's Healthcare NHS Trust;Barnet and Chase Farm Hospitals NHS TrustCompleted18 Years60 YearsAll30Phase 2United Kingdom
559NCT02205489
(ClinicalTrials.gov)
October 201429/7/2014Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADASingle Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADARelapsing-remitting Multiple SclerosisDrug: Alemtuzumab GZ402673;Drug: cetirizine;Drug: ranitidine;Drug: methylprednisolone;Drug: aciclovir;Drug: esomeprazole;Drug: ibuprofen;Drug: paracetamolGenzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth58Phase 4Belgium;France;Netherlands;Spain
560NCT02241785
(ClinicalTrials.gov)
September 30, 201412/9/2014Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other TherapiesA Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenya® to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS)Relapsing Multiple SclerosisDrug: natalizumabBiogenNULLTerminated18 Years60 YearsAll47Phase 4United States;Germany
561NCT02232061
(ClinicalTrials.gov)
September 29, 20142/9/2014Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With FingolimodLong-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With FingolimodMultiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLCompletedN/AN/AAll6Phase 4Belgium;Germany;Italy
562EUCTR2013-001150-10-AT
(EUCTR)
16/09/201417/02/2014STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT neuromyelitis optica
MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden
563EUCTR2014-000092-62-NL
(EUCTR)
04/09/201430/06/2014Management of the infusion-associated reactions in RRMS patients treated with LemtradaSingle arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD Relapsing-remitting multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
56Phase 4France;Belgium;Spain;Netherlands;Switzerland
564NCT02219932
(ClinicalTrials.gov)
September 201418/8/2014Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple SclerosisA Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects With Multiple Sclerosis (ENHANCE)Multiple SclerosisDrug: fampridine;Drug: PlaceboBiogenNULLCompleted18 Years70 YearsAll646Phase 3United States;Bulgaria;Czech Republic;Finland;Italy;Lithuania;Netherlands;Poland;Russian Federation;Serbia;United Kingdom;Argentina;Germany;Switzerland
565NCT02045732
(ClinicalTrials.gov)
September 201422/1/2014A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)A Phase 1b, Double-blinded, Placebo-controlled, Randomized Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Subjects With Multiple Sclerosis (ms)Multiple SclerosisBiological: PF-06342674 0.25 mg/kg;Biological: Placebo;Biological: PF-06342674 1.5 mg/kg;Biological: PF-06342674 6.0 mg/kgPfizerNULLTerminated18 Years55 YearsAll4Phase 1United States
566NCT02282878
(ClinicalTrials.gov)
September 201431/10/2014The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple SclerosisThe Effect of Dietary Salt Intake on Immune Function in Patients With Multiple SclerosisMultiple SclerosisDietary Supplement: High/Low Sodium DietYale UniversityNULLCompleted18 Years60 YearsAll14N/AUnited States
567EUCTR2014-000092-62-ES
(EUCTR)
28/08/201404/07/2014Management of the infusion-associated reactions in RRMS patients treated with LemtradaSingle arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD Relapsing-remitting multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
56Phase 4France;Belgium;Spain;Netherlands;Switzerland
568NCT02283853
(ClinicalTrials.gov)
August 28, 20143/11/2014Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)Open-Label, Randomized, Multicenter, Multiple-Dose,Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label ExtensionRelapsing-Remitting Multiple SclerosisDrug: dimethyl fumarate;Drug: Interferon ß-1aBiogenNULLActive, not recruiting10 Years17 YearsAll156Phase 3United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Kuwait;Poland;Serbia;Spain;Sweden;Turkey;United Kingdom;Argentina;Czech Republic;Romania
569EUCTR2014-000092-62-FR
(EUCTR)
22/08/201418/06/2015Management of the infusion-associated reactions in RRMS patients treated with LemtradaSingle arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD Relapsing-remitting multiple sclerosis
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: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
56Phase 4France;Spain;Belgium;Netherlands;Switzerland
570NCT02073279
(ClinicalTrials.gov)
August 5, 201425/2/2014Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)Drug: Satralizumab;Drug: PlaceboHoffmann-La RocheChugai PharmaceuticalActive, not recruiting18 Years74 YearsAll95Phase 3United States;Bulgaria;Canada;Croatia;Georgia;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Puerto Rico;Romania;Taiwan;Turkey;Ukraine;Bosnia and Herzegovina;Singapore
571EUCTR2014-000092-62-BE
(EUCTR)
30/07/201410/06/2014Management of the infusion-associated reactions in RRMS patients treated with LemtradaSingle arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD 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: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
56Phase 4France;Spain;Belgium;Netherlands;Switzerland
572EUCTR2013-001151-12-AT
(EUCTR)
23/07/201414/02/2014EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
573NCT02201108
(ClinicalTrials.gov)
July 16, 201417/7/2014Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple SclerosisA 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 ExtensionMultiple SclerosisDrug: Teriflunomide;Drug: PlaceboGenzyme, a Sanofi CompanyNULLActive, not recruiting10 Years17 YearsAll166Phase 3United States;Belgium;Bulgaria;Canada;China;Estonia;France;Greece;Israel;Lebanon;Lithuania;Morocco;Netherlands;North Macedonia;Portugal;Russian Federation;Serbia;Slovenia;Spain;Tunisia;Turkey;Ukraine;United Kingdom;Australia;Macedonia, The Former Yugoslav Republic of;Poland
574NCT02217982
(ClinicalTrials.gov)
July 201430/7/2014Pilot Study to Assess Dimethyl Fumarate Related GI Symptom MitigationA Pilot Study to Assess Dimethyl Fumarate (Tecfidera) Related GI Symptom Mitigation Via Food Bolus Alteration and Simethicone/Loperamide AdministrationRelapsing Remitting Multiple SclerosisDrug: Simethicone;Drug: Loperamide;Other: Peanut ButterRocky Mountain MS Research Group, LLCBiogenTerminated18 YearsN/AAll5Phase 4United States
575NCT02137044
(ClinicalTrials.gov)
July 201422/4/2014Multiple Sclerosis-Collaborative Approach to Rehabilitation Effectiveness StudyImproving the Quality of Care for Pain and Depression in Persons With Multiple SclerosisMultiple Sclerosis;Pain;DepressionBehavioral: Collaborative Care (CC)University of WashingtonPatient-Centered Outcomes Research InstituteCompleted18 YearsN/AAll195N/AUnited States
576NCT02207075
(ClinicalTrials.gov)
July 201430/7/2014Measuring Active Microglia in Progressive Multiple SclerosisMeasuring Active Microglia in Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisDrug: [C11]PK-1195 PET scanWeill Medical College of Cornell UniversityGenzyme, a Sanofi CompanyCompleted18 Years80 YearsAll50United States
577NCT02201849
(ClinicalTrials.gov)
July 201418/7/2014A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy AdultsA Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy AdultsMultiple SclerosisDrug: Study Drug;Drug: Active Control;Drug: PlaceboBiogenNULLCompleted18 Years55 YearsAll104Phase 1United States
578NCT02121444
(ClinicalTrials.gov)
June 23, 201422/4/2014BAY86-5046 (Betaseron), Non Interventional StudiesBETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®Multiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY 86-5046);Device: BETACONNECT auto-injector.BayerNULLCompleted18 YearsN/AAll151N/AGermany
579NCT01941004
(ClinicalTrials.gov)
June 20149/9/2013Safety and Efficacy of Fingolimod in MS Patients in ChinaA 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple SclerosisMultiple Sclerosis (Relapsing Remitting)Drug: fingolimod;Drug: Placebo (6mos) + open label fingolimod (6 mos)Novartis PharmaceuticalsNULLWithdrawn18 Years50 YearsAll0Phase 3NULL
580NCT02258217
(ClinicalTrials.gov)
June 20142/10/2014Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)Relapsing Remitting Multiple SclerosisDrug: ActharOhioHealthNULLCompleted18 YearsN/AAll30N/AUnited States
581NCT02117050
(ClinicalTrials.gov)
June 201415/4/2014RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl FumarateRESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw)Multiple SclerosisDrug: Rebif®EMD SeronoNULLTerminated18 Years65 YearsAll1Phase 4United States
582NCT02133664
(ClinicalTrials.gov)
June 20146/5/2014Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple SclerosisLipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple SclerosisMultiple Sclerosis;CognitionDrug: lipoic acid and omega-3 fatty acids;Drug: PlaceboOregon Health and Science UniversityNational Multiple Sclerosis SocietyCompleted18 Years65 YearsAll54Phase 1/Phase 2United States
583NCT02125604
(ClinicalTrials.gov)
June 201425/4/2014Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In GermanyA Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects With Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)Relapsing-Remitting Multiple SclerosisDrug: dimethyl fumarateBiogenNULLCompleted18 YearsN/AAll214Phase 4Germany
584NCT02064816
(ClinicalTrials.gov)
May 31, 201413/2/2014A Study of Rebif® in Subjects With Relapsing Multiple SclerosisMulticenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Rebif®Merck KGaA, Darmstadt, GermanyNULLCompleted18 Years60 YearsAll200Phase 4Germany
585EUCTR2013-001151-12-FR
(EUCTR)
13/05/201425/09/2015EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Relapsing Neuromyelitis Optica
MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
93 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
586EUCTR2013-001150-10-FR
(EUCTR)
13/05/201421/09/2015STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Relapsing neuromyelitis optica
MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
93 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden
587NCT02090413
(ClinicalTrials.gov)
May 201414/3/2014Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple SclerosisA Phase 4, Randomized, Double-Blind Study With a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects With Relapsing-Remitting Multiple Sclerosis Treated With Tecfidera® (Dimethyl Fumarate) Delayed-Release CapsulesRelapsing-Remitting Multiple SclerosisDrug: dimethyl fumarate;Drug: acetylsalicylic acid;Drug: ASA-PlaceboBiogenNULLCompleted18 YearsN/AAll241Phase 4Ireland;United Kingdom
588NCT02086188
(ClinicalTrials.gov)
May 201411/3/2014Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple SclerosisPilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Multiple Sclerosis (MIRROR)Multiple SclerosisDrug: Mirabegron;Drug: PlaceboTheodore R. Brown, MD MPHAstellas Pharma IncCompleted18 YearsN/AAll28Phase 4United States
589NCT02143167
(ClinicalTrials.gov)
May 20149/5/2014Resistance Training and Amino Pyridine in Multiple SclerosisRETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple SclerosisMultiple SclerosisDrug: SR-fampridine;Drug: PlaceboUniversity of Southern DenmarkRegion of Southern Denmark;BiogenCompleted18 Years60 YearsAll40Phase 4Denmark
590NCT02579681
(ClinicalTrials.gov)
April 30, 201416/10/2015Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012Multiple Sclerosis, Relapsing-RemittingDrug: dimethyl fumarateBiogenNULLCompleted18 YearsN/AAll221Phase 3Italy
591NCT01892345
(ClinicalTrials.gov)
April 11, 201420/6/2013A 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 DisorderDrug: Eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLTerminated18 YearsN/AAll143Phase 3United 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
592EUCTR2012-000734-19-ES
(EUCTR)
10/04/201410/01/2014Bone marrow cell treatment as treatment of multiple sclerosisTreatment 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 TeixitsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
593NCT04256252
(ClinicalTrials.gov)
April 20142/2/2020Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical TrialNeuromyelitis Optica Spectrum DisorderDrug: RituximabTang-Du HospitalNULLCompleted16 Years75 YearsAll108Phase 4NULL
594NCT01973517
(ClinicalTrials.gov)
April 201416/10/2013High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating DiseasesMultiple SclerosisDrug: Feraheme;Drug: Gadolinium-based contrastStanford UniversityNULLWithdrawn18 YearsN/AAll0United States
595NCT02227524
(ClinicalTrials.gov)
April 201420/8/2014Trekking Poles to Aid Multiple Sclerosis Gait ImpairmentTrekking Poles to Aid Multiple Sclerosis Gait ImpairmentMultiple SclerosisOther: No device;Device: Single-point cane (SPC);Device: Four-point cane (FPC);Device: Trekking pole (TP).Rowan UniversityNULLCompleted18 Years64 YearsAll29N/AUnited States
596NCT01933802
(ClinicalTrials.gov)
April 201423/8/2013Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple SclerosisPhase 1 Safety Study of Autologous Bone Marrow-derived Mesenchymal Stem Cell-derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo, Administered Intrathecally in Patients With Multiple SclerosisMultiple SclerosisBiological: intrathecal administration of autologous MSC-NPTisch Multiple Sclerosis Research Center of New YorkNULLCompleted18 Years70 YearsAll20Phase 1United States
597NCT02087813
(ClinicalTrials.gov)
March 201411/3/2014Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica RelapsesA Single Center Open Label Pilot Study of Alpha1-Antitrypsin: A Novel Treatment to Mitigate Neuromyelitis Optica AttacksNeuromyelitis OpticaDrug: Alpha1-antitrypsin;Drug: methylprednisoloneStanford UniversityNULLWithdrawn18 Years75 YearsAll0Phase 1United States
598NCT02084121
(ClinicalTrials.gov)
March 20147/3/2014Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis (Compassionate Use)Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis (Compassionate Use)Metachromatic LeukodystrophyBiological: Enriched Hematopoetic Stem Cell InfusionTalaris Therapeutics Inc.Duke UniversityNo longer available3 YearsN/AMaleUnited States
599NCT01973491
(ClinicalTrials.gov)
February 28, 201423/10/2013ATX-MS-1467 in Multiple SclerosisAn Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and Its Effect on Immune Tolerance in Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: ATX-MS-1467Merck KGaANULLCompleted18 Years65 YearsAll37Phase 2Germany
600NCT02208050
(ClinicalTrials.gov)
February 21, 201419/5/2014A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MSA Phase IV Double Blind, Randomized, Placebo Controlled, Crossover Study of the Effectiveness of Oral Fampridine in Improving Upper Limb Function in Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Fampridine;Drug: PlaceboUniversity College DublinNULLCompleted18 Years70 YearsAll64Phase 4Ireland
601NCT02028884
(ClinicalTrials.gov)
February 20, 20146/1/2014Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)Drug: Satralizumab;Drug: Placebo;Drug: Baseline TreatmentHoffmann-La RocheChugai PharmaceuticalActive, not recruiting12 Years74 YearsAll83Phase 3United States;France;Germany;Hungary;Italy;Japan;Poland;Spain;Taiwan;Ukraine;United Kingdom
602EUCTR2013-001151-12-GB
(EUCTR)
18/02/201425/07/2013EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United States;Taiwan;Hong Kong;Spain;Russian Federation;Colombia;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
603EUCTR2013-001150-10-GB
(EUCTR)
18/02/201425/07/2013STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA 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
MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
604NCT02849782
(ClinicalTrials.gov)
February 4, 201422/7/2016Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine.Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor PerformancesMultiple SclerosisDrug: FampridineCentre Hospitalier Universitaire de BesanconNULLCompleted18 Years80 YearsAll89Phase 4France
605NCT02065284
(ClinicalTrials.gov)
February 201413/2/2014Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple SclerosisEffects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.Multiple Sclerosis;Ambulation DifficultyOther: Rhythmic Auditory Stimulation (RAS)The Cleveland ClinicThe Kelvin and Eleanor Smith FoundationCompleted18 YearsN/AAll32N/AUnited States
606NCT02166346
(ClinicalTrials.gov)
February 201416/6/2014Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)Double-Blind, Placebo-Controlled Crossover Trial on the Safety and Efficacy of Sustained-Release Dalfampridine in Transverse Myelitis (Re-Launch)Transverse Myelitis;Neuromyelitis Optica;Idiopathic Transverse Myelitis;Myelitis NOSDrug: Dalfampridine;Drug: PlaceboJohns Hopkins UniversityAcorda TherapeuticsCompleted18 Years70 YearsAll24Phase 2United States
607NCT01975298
(ClinicalTrials.gov)
January 201428/10/2013A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).Relapsing Remitting Multiple SclerosisDrug: Laquinimod;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLWithdrawn18 Years55 YearsAll0Phase 3Belgium;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
608NCT02034188
(ClinicalTrials.gov)
January 20149/1/2014Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple SclerosisFeasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple SclerosisMultiple SclerosisBiological: Umbilical cord mesenchymal stem cellsTranslational BiosciencesNULLCompleted18 Years55 YearsAll20Phase 1/Phase 2Panama
609NCT04265092
(ClinicalTrials.gov)
January 201422/10/2019Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple SclerosisGaitox :Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis an Observational Study on Gait Spatiotemporal ParametersMultiple SclerosisDrug: Incobotulinum toxin APôle Saint HélierNULLCompleted18 YearsN/AAll22NULL
610NCT02038049
(ClinicalTrials.gov)
December 20, 201314/1/2014A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple SclerosisA Randomized, Partially Blind, Placebo-controlled, Proof-of-concept Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity as Measured by Brain MRI Scans in Patients With Relapsing-remitting Multiple SclerosisRelapse Remitting Multiple SclerosisDrug: VAY736;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years55 YearsAll8Phase 2United States;Czechia;Ukraine;Czech Republic;Germany;Poland;Russian Federation
611EUCTR2013-004626-28-FI
(EUCTR)
20/12/201320/11/2013Does targeting of S1P receptors reduce microglial activation in multiple sclerosis?Does targeting of S1P receptors reduce microglial activation in multiple sclerosis? Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: REBIF
Product Name: beetainterferoni -1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Gilenya
Product Name: Fingolimodi
Other descriptive name: FINGOLIMOD
Trade Name: Avonex
Trade Name: Betaferon
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Lemtrada
Other descriptive name: ALEMTUZUMAB
Turku University HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Finland
612EUCTR2013-001150-10-DE
(EUCTR)
12/12/201302/07/2013STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT Neuromyelitis Optica
MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden
613EUCTR2013-001151-12-DE
(EUCTR)
12/12/201302/07/2013EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
614NCT02047734
(ClinicalTrials.gov)
December 3, 201326/1/2014Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study)A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis PatientsRelapsing Multiple SclerosisDrug: Ozanimod 0.5 mg;Drug: Ozanimod 1 mg;Drug: Ozanimod placebo;Drug: Interferon ß-1a;Drug: IFN ß-1a placeboCelgeneNULLCompleted18 Years55 YearsAll1320Phase 3United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Georgia;Greece;Hungary;Italy;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom
615NCT02146534
(ClinicalTrials.gov)
December 201323/4/2014Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS PatientsProlonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: a Phase IV, Double-blind, Placebo-controlled Study.Multiple SclerosisDrug: extended release fampridine;Drug: PlaceboClinique Neuro-OutaouaisCogState Ltd.Completed18 YearsN/AAll44Phase 4Canada
616NCT02047097
(ClinicalTrials.gov)
November 19, 201324/1/2014Dimethyl Fumarate (DMF) Observational StudyA Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)Multiple SclerosisDrug: dimethyl fumarateBiogenNULLActive, not recruiting18 YearsN/AAll5496United States;Argentina;Australia;Austria;Canada;Czechia;Denmark;France;Germany;Hungary;Ireland;Italy;Netherlands;New Zealand;Norway;Poland;Portugal;Puerto Rico;Slovakia;Spain;Switzerland;United Kingdom;Czech Republic
617NCT04832399
(ClinicalTrials.gov)
November 12, 201316/3/2021Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis ParticipantsTysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT)Relapsing Remitting Multiple SclerosisDrug: NatalizumabBiogenNULLRecruiting18 Years55 YearsAll60Portugal
618EUCTR2012-004165-41-GB
(EUCTR)
04/11/201319/09/2013Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyHematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: natalizumab
Trade Name: Fingolimod
Product Name: Gilenya
INN or Proposed INN: Fingolimod
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG-12 120
INN or Proposed INN: dimethyl fumarate
Northwestern UniversityNULLNot RecruitingFemale: yes
Male: yes
110Phase 2United States;United Kingdom
619NCT03133403
(ClinicalTrials.gov)
November 201321/4/2016Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved TherapyHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT)Sheffield Teaching Hospitals NHS Foundation TrustNULLRecruiting18 Years55 YearsAll5Phase 2/Phase 3United Kingdom
620NCT01939002
(ClinicalTrials.gov)
November 201323/8/2013Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017)An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017Relapsing Multiple SclerosisDrug: BIIB017;Drug: naproxenBiogenNULLCompleted18 Years65 YearsAll251Phase 3United States
621NCT01982942
(ClinicalTrials.gov)
November 201329/10/2013Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple SclerosisA Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple SclerosisMultiple Sclerosis, Primary Progressive;Multiple Sclerosis, Secondary ProgressiveDrug: ibudilast;Drug: Placebo oral capsuleMediciNovaNational Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS);National Multiple Sclerosis SocietyCompleted21 Years65 YearsAll255Phase 2United States
622NCT01968902
(ClinicalTrials.gov)
November 201321/10/2013Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis PatientsA Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Incobotulinumtoxin Type A for the Functional Improvement of Lower Extremity Spasticity in Patients With Multiple SclerosisMuscle Spasticity;Multiple SclerosisBiological: incabotulinumtoxinA;Biological: PlaceboMultiple Sclerosis Center of Northeastern New YorkMerz North America, Inc.Completed18 Years65 YearsAll27Phase 4United States
623NCT01930708
(ClinicalTrials.gov)
October 31, 201315/8/2013A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported OutcomesA 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 SettingRelapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: dimethyl fumarateBiogenNULLCompleted18 YearsN/AAll1114Phase 4Austria;Belgium;Canada;Czechia;France;Hungary;Italy;Portugal;Slovakia;Slovenia;Spain;Czech Republic
624EUCTR2013-001150-10-ES
(EUCTR)
17/10/201308/08/2013STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Relapsing neuromyelitis optica
MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
93Phase 3United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
625EUCTR2013-001151-12-ES
(EUCTR)
17/10/201308/08/2013EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Relapsing Neuromyelitis Optica
MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
93Phase 3United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Japan;Sweden
626NCT01326715
(ClinicalTrials.gov)
October 17, 201330/3/2011Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple SclerosisManganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple SclerosisMultiple SclerosisDrug: Mangafodipir (Teslascan)National Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 Years70 YearsAll17Phase 1United States
627NCT01970410
(ClinicalTrials.gov)
October 201322/10/2013Sub-Study: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide - SWITCH-JCVSwitching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? (Sub-study: SWITCH-JCV)Multiple SclerosisDrug: teriflunomideProvidence Health & ServicesMultiple Sclerosis Center of Northeastern New YorkActive, not recruiting21 Years60 YearsAll41Phase 4United States
628NCT02220933
(ClinicalTrials.gov)
October 201318/8/2014Effect of MD1003 in Spinal Progressive Multiple SclerosisEffect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled StudyMultiple SclerosisDrug: MD1003 100mg capsule;Drug: PlaceboMedDay Pharmaceuticals SANULLActive, not recruiting18 Years75 YearsAll144Phase 3France
629NCT01963611
(ClinicalTrials.gov)
October 201311/10/2013Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Plovamer acetate 0.5 milligram (mg);Drug: Copaxone 20 mg;Drug: Plovamer acetate 3 mg;Drug: Plovamer acetate 10 mg;Drug: Plovamer acetate 20 mgEMD SeronoNULLTerminated18 Years60 YearsAll255Phase 2United States;Bulgaria;Croatia;Czech Republic;Finland;Greece;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Germany
630NCT01911377
(ClinicalTrials.gov)
October 201325/7/2013Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MSThe Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple SclerosisNeuropathic Pain;AllodyniaDrug: Botulinum Toxin Type A;Drug: Normal Saline for InjectionUniversity of ManitobaAllerganTerminated18 Years70 YearsBoth12Phase 2Canada
631NCT02220244
(ClinicalTrials.gov)
October 201318/8/2014Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple SclerosisEffect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled StudyMultiple SclerosisDrug: MD1003 100mg capsuleMedDay Pharmaceuticals SANULLActive, not recruiting18 Years75 YearsAll105Phase 3France;United Kingdom
632NCT01950234
(ClinicalTrials.gov)
October 201330/8/2013ACTH in Progressive Forms of MSTreatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis;Progressive Relapsing Multiple SclerosisDrug: ACTH;Drug: PlaceboUniversity of MinnesotaMallinckrodtActive, not recruiting18 YearsN/AAll100Phase 2United States
633NCT02753088
(ClinicalTrials.gov)
October 201319/4/2016Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple SclerosisInternational, Multicentre, Double-blind, Placebo-controlled, Comparative, Randomized Study to Compare Efficacy and Safety of the Generic Drug BCD-063 (CJSC BIOCAD, Russia) and Copaxone®-Teva (Teva Pharmaceutical Industries Limited, Israel) in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: BCD-063;Drug: Copaxone-Teva;Drug: PlaceboBiocadNULLCompleted18 Years55 YearsAll158Phase 3NULL
634EUCTR2013-001150-10-IT
(EUCTR)
17/09/201309/07/2013A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 Relapsing neuromyelitis optica
MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
93Phase 3United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
635EUCTR2013-001151-12-IT
(EUCTR)
17/09/201309/07/2013EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 Relapsing Neuromyelitis Optica
MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
93Phase 3United States;United Arab Emirates;Taiwan;Saudi Arabia;Hong Kong;Spain;Russian Federation;Chile;Colombia;Italy;France;Peru;Australia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Belgium;Brazil;Singapore;Germany;Japan;Sweden
636EUCTR2012-003647-30-AT
(EUCTR)
27/08/201307/02/2013A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
637NCT01917019
(ClinicalTrials.gov)
August 20132/8/2013A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple SclerosisA Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety ExtensionMultiple Sclerosis, Remittent Progressive;Multiple Sclerosis, Primary Progressive;Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Multiple SclerosisDrug: Placebo;Drug: BIIB041 (fampridine)BiogenNULLCompleted18 Years70 YearsAll101Phase 3Japan
638NCT01864148
(ClinicalTrials.gov)
August 201324/5/2013Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With AvonexA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With AvonexMultiple SclerosisDrug: BIIB033;Other: Placebo;Drug: AvonexBiogenNULLCompleted18 Years58 YearsAll419Phase 2United States;Canada;Czech Republic;France;Hungary;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom
639NCT02290444
(ClinicalTrials.gov)
August 201323/10/2014Effects of Acthar on Recovery From Cognitive Relapses in MSEffects of Adrenocorticotropic Hormone (ACTHAR Gel) on Recovery From Cognitive Relapses in Multiple SclerosisMultiple SclerosisDrug: Adrenocorticotropic HormoneState University of New York at BuffaloNULLCompleted18 Years65 YearsAll64Phase 3United States
640NCT02225977
(ClinicalTrials.gov)
July 31, 201324/8/2014Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.Multiple SclerosisDrug: GilenyaUniversity of Southern CaliforniaNULLCompleted18 Years65 YearsAll125United States
641NCT01892722
(ClinicalTrials.gov)
July 26, 20138/5/2013Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple SclerosisA 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon ß-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension PhaseMultiple SclerosisDrug: Interferon beta-1a;Drug: Fingolimod;Drug: Placebo capsule;Drug: Placebo i.m. injectionNovartis PharmaceuticalsNULLRecruiting10 Years17 YearsAll220Phase 3United States;Australia;Austria;Belarus;Brazil;Bulgaria;Canada;Croatia;Estonia;France;Germany;Italy;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;South Africa
642JPRN-UMIN000011111
2013/07/1615/07/2013Spinal blood flow and metabolism in neurological diseases motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophyPET scan study with 11C-flumazenil
PET scan study with 18F- FDG
PET scan study with 15O-H2O
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesNULLRecruiting20years-oldNot applicableMale and Female70Not applicableJapan
643NCT01817166
(ClinicalTrials.gov)
July 16, 201320/3/2013Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated SyndromeMulticentric, Randomized, Double-blind Versus Placebo Study Evaluating the Efficacy of Treatment With Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of Multiple Sclerosis (MS) After a Clinically Isolated Syndrome (CIS). Comparison of Conversion Rates After 2 Years.Multiple SclerosisDrug: Vitamin D;Drug: Placebo;Other: Imaging;Biological: Lumbar puncture;Biological: Blood sampling;Biological: Urine samplesCentre Hospitalier Universitaire de NimesNULLActive, not recruiting18 Years56 YearsAll316Phase 3France
644EUCTR2012-003647-30-CZ
(EUCTR)
08/07/201328/11/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
645NCT02076841
(ClinicalTrials.gov)
July 201319/2/2014Tolerability and Quality of Life Study in Participants Who Switched to Avonex PenTolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)Relapsing-Remitting Multiple Sclerosis;Clinical Isolated Syndrome (CIS);Multiple SclerosisDevice: interferon beta-1aBiogenNULLCompleted18 YearsN/AAll40N/ACzech Republic;Switzerland
646NCT01900093
(ClinicalTrials.gov)
July 201311/7/2013Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS RelapsesAn Open-Label Prospective Proof-Of-Concept Trial to Evaluate the Response to Acthar Gel Therapy in Patients With Multiple Sclerosis (MS) Relapses Who Have Failed To Make an Adequate Recovery After Treatment With High-Dose Intravenous MethylprednisoloneMultiple SclerosisDrug: Acthar GelAaron MillerMallinckrodtRecruiting18 Years65 YearsAll10N/AUnited States
647NCT01647880
(ClinicalTrials.gov)
July 201323/7/2012MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic NeuritisMultiple SclerosisDrug: Verum arm receiving Gilenya®;Drug: Active Comparator receiving Extavia®Charite University, Berlin, GermanyNeuroCure Clinical Research Center, Charite, BerlinTerminated18 Years55 YearsAll15Phase 2/Phase 3Germany
648NCT01896700
(ClinicalTrials.gov)
July 20138/7/2013Methylphenidate to Improve Balance and Walking in MSMethylphenidate to Improve Balance and Walking in MSMultiple SclerosisDrug: Methylphenidate;Drug: PlaceboOregon Health and Science UniversityPortland VA Medical CenterCompleted20 Years65 YearsAll24Phase 2/Phase 3United States
649NCT02048072
(ClinicalTrials.gov)
July 201327/1/2014Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MSFunktionelle Evaluation Des Autonomen Nervensystems im Zusammenhang Mit Der Erstmaligen Einnahme Von 0,5mg Fingolimod (Gilenya) Bei Patienten Mit schubförmig Verlaufender Multipler SkleroseMultiple Sclerosis;Autonomic Nervous System DysfunctionDrug: GilenyaJochen VehoffNULLCompleted18 Years60 YearsAll33Phase 4Switzerland
650NCT01710228
(ClinicalTrials.gov)
July 20134/9/2012Alternative Treatment Paradigm for Natalizumab TrialAlternative Treatment Paradigm for Natalizumab TrialMultiple Sclerosis (MS)Drug: methylprednisoloneUniversity of Texas Southwestern Medical CenterTeva Pharmaceutical Industries;The University of Texas Health Science Center, Houston;University of Alabama at Birmingham;Charite University, Berlin, GermanyWithdrawn18 Years60 YearsBoth0Phase 2United States
651NCT03216915
(ClinicalTrials.gov)
June 1, 201322/6/2017Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple SclerosisFINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple SclerosisMultiple SclerosisDrug: Gilenya®; Novartis Pharmaceuticals CorporationUniversitätsklinikum Hamburg-EppendorfNULLRecruiting18 YearsN/AAll100Germany
652NCT01651520
(ClinicalTrials.gov)
June 201325/7/2012Prognosis Value of the Neuronal Damage in Early Multiple SclerosisPrognosis Value of the Neuronal Damage Detected by Positrons Emission Tomography (PET) With 11C-Flumazenil in Early Multiple Sclerosis.Multiple SclerosisDrug: PET with 11C-FlumazenilAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting18 Years55 YearsAll60N/AFrance
653NCT01777412
(ClinicalTrials.gov)
June 201321/1/2013Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO ExacerbationsAn Open-label Phase 1b Study of Avastin® (Bevacizumab) for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD).Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: BevacizumabJohns Hopkins UniversityGenentech, Inc.;Guthy Jackson Charitable FoundationCompleted18 Years70 YearsAll10Phase 1United States
654NCT01621269
(ClinicalTrials.gov)
June 201324/4/2012ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against InterferonA 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon BetaMultiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLWithdrawn18 Years65 YearsAll0Phase 4Germany
655NCT01874340
(ClinicalTrials.gov)
June 201328/5/2013Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple SclerosisA Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: AIN457Novartis PharmaceuticalsNULLTerminated18 Years55 YearsAll28Phase 2Belgium;Czech Republic;France;Italy;Japan;Poland;Russian Federation;Spain;Sweden;Turkey;Canada;Finland;Germany;Romania;Switzerland;United States
656NCT01895335
(ClinicalTrials.gov)
June 20133/7/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) PatientsMultiple SclerosisDrug: TeriflunomideSanofiNULLCompleted18 YearsN/AAll1001Phase 4United States;Austria;Belgium;Canada;Chile;Finland;France;Germany;Greece;Italy;Norway;Spain;Sweden;United Kingdom
657NCT01874145
(ClinicalTrials.gov)
June 20136/6/2013Safety and Tolerability of Glatiramer AcetateAn Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: GA 20 mg/mL;Drug: GA 40 mg/mLTeva Pharmaceutical IndustriesNULLCompleted18 YearsN/AAll209Phase 3United States
658NCT01854359
(ClinicalTrials.gov)
May 11, 201311/5/2013Idebenone for Primary Progressive Multiple SclerosisOpen Label Extension Trial of Idebenone for Primary Progressive Multiple SclerosisMultiple Sclerosis;Primary Progressive Multiple SclerosisDrug: IdebenoneNational Institute of Allergy and Infectious Diseases (NIAID)NULLUnknown status18 YearsN/AAll61Phase 1/Phase 2United States
659NCT01845584
(ClinicalTrials.gov)
May 201326/4/2013Phase 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 DisorderDrug: NPB-01Nihon Pharmaceutical Co., LtdNULLCompleted20 YearsN/AAll7Phase 2Japan
660NCT01873417
(ClinicalTrials.gov)
May 20139/5/2013Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United StatesA Multicenter, Open-Label, Single-Arm Study of Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera™ (Dimethyl Fumarate) Delayed-release CapsulesRelapsing Forms of Multiple SclerosisDrug: BG00012 (DMF)BiogenNULLCompleted18 YearsN/AAll237Phase 4United States
661NCT01838174
(ClinicalTrials.gov)
May 201318/4/2013A Trial of Neuroprotection With ACTH in Acute Optic NeuritisA Phase IV Trial of Neuroprotection With ACTH in Acute Optic NeuritisMultiple SclerosisDrug: ACTHAR Gel (ACTH);Drug: IV methylprednisolone (steroids)University of Colorado, DenverMallinckrodt;University of PennsylvaniaTerminated18 Years55 YearsAll100Phase 4United States
662EUCTR2012-005507-40-IT
(EUCTR)
15/04/201325/02/2013Study to provide access to fingolimod to Multiple Sclerosis patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drugAn open-label, single arm study to provide access to fingolimod to MS patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
NOVARTIS FARMA S.p.ANULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
663EUCTR2012-003647-30-PL
(EUCTR)
11/04/201312/02/2013A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;Estonia
664NCT01767701
(ClinicalTrials.gov)
April 20137/1/2013Raltegravir (Isentress) Pilot Study in Relapsing Multiple SclerosisA Phase II Baseline Versus Treatment Study to Determine the Efficacy of Raltegravir (Isentress) in Preventing Progression of Relapsing Remitting Multiple Sclerosis as Determined by Gadolinium-enhanced MRIRelapsing Remitting Multiple SclerosisDrug: RaltegravirQueen Mary University of LondonMerck Sharp & Dohme Corp.Completed18 Years55 YearsAll23Phase 2United Kingdom
665NCT01844232
(ClinicalTrials.gov)
April 201324/4/2013One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With SpasticityA One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With SpasticityMultiple Sclerosis;SpasticityDrug: arbaclofenOsmotica Pharmaceutical US LLCNULLCompleted18 Years70 YearsAll150Phase 3United States;Russian Federation;Ukraine
666NCT01738347
(ClinicalTrials.gov)
April 201313/11/2012Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the Imaging Protocol of GEH120714 (18F) Injection, a Marker of Microglial Activation, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS)Relapsing-remitting Multiple Sclerosis (rrMS)Drug: Arm 1 - GEH120714 (18F) InjectionGE HealthcareCentre for Probe Development and CommercializationCompleted20 Years50 YearsAll30Phase 1Canada;United States
667NCT01838668
(ClinicalTrials.gov)
March 28, 201320/4/2013An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: Placebo;Drug: dimethyl fumarateBiogenNULLCompleted18 Years55 YearsAll225Phase 3Czechia;Japan;Korea, Republic of;Poland;Taiwan;Czech Republic
668EUCTR2012-000957-30-GB
(EUCTR)
05/03/201312/12/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® 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: 14.1;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.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom
669NCT01834586
(ClinicalTrials.gov)
March 20132/4/2013Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis MedicationsPilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)Multiple SclerosisDrug: Anesthetic Topical Adhesive SyneraBrown, Theodore R., M.D., MPHNULLCompleted18 YearsN/AAll30Phase 4United States
670NCT01791244
(ClinicalTrials.gov)
February 28, 201312/2/2013A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ DeviceA Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program (MinSupport Plus) on Health Related Quality of Life (HRQoL) and Adherence in Patients With Relapsing Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart DeviceMultiple Sclerosis;Relapsing-RemittingDrug: Rebif®Merck KGaANULLCompleted18 YearsN/AAll93Phase 4Germany;Sweden
671NCT01707992
(ClinicalTrials.gov)
February 20, 201328/9/2012The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Laquinimod;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years55 YearsAll2199Phase 3United States;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Montenegro;North Macedonia;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom;Czech Republic;Kazakhstan;Macedonia, The Former Yugoslav Republic of;Mexico;Portugal
672NCT01797965
(ClinicalTrials.gov)
February 15, 201315/2/2013Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301Relapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: BIIB019 (Daclizumab)BiogenAbbVieTerminated18 YearsN/AAll1501Phase 3United States;Argentina;Australia;Brazil;Canada;Czechia;Denmark;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;China;Czech Republic;Finland
673NCT02040116
(ClinicalTrials.gov)
February 201314/1/2014Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune DiseasesStudy Evaluating Rapid Infusion Rituximab in Patients With Autoimmune DiseasesMultiple SclerosisDrug: Rituximab InfusionWake Forest University Health SciencesNULLCompleted18 Years80 YearsAll19Phase 4United States
674NCT01848327
(ClinicalTrials.gov)
February 201316/4/2013Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple SclerosisA Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.Relapsing Remitting MS;Secondary Progressive MS;Primary Progressive MSDietary Supplement: Caprylic Triglyceride;Dietary Supplement: PlaceboUniversity of MiamiNational Multiple Sclerosis Society;CerecinCompleted18 Years59 YearsAll124N/AUnited States
675NCT01802489
(ClinicalTrials.gov)
February 201327/2/2013Amiloride Clinical Trial In Optic NeuritisA Double Blind Randomised Control Trial on Neuroprotection of Amiloride in Optic NeuritisOptic Neuritis;Multiple SclerosisDrug: Amiloride;Drug: PlaceboUniversity of OxfordMultiple Sclerosis Society of Great Britain and Northern IrelandCompleted18 Years55 YearsAll46Phase 2United Kingdom
676EUCTR2012-000957-30-PT
(EUCTR)
29/01/201312/11/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® 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: 14.1;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.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom
677EUCTR2012-003647-30-BE
(EUCTR)
18/01/201308/10/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Belarus;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany
678EUCTR2012-003647-30-ES
(EUCTR)
04/01/201329/10/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany
679EUCTR2012-003647-30-HU
(EUCTR)
04/01/201325/10/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
680EUCTR2012-003647-30-EE
(EUCTR)
03/01/201319/11/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
681NCT04823000
(ClinicalTrials.gov)
January 1, 201311/1/2021Effects of Repeated Mesenchymal Stem Cells (MSC) in Patients With Progressive Multiple SclerosisLong Term Clinical and Immunological Effects of Repeated Mesenchymal Stem Cells (MSC) Injections in Patients With Progressive Forms of Multiple Sclerosis (MS)Multiple SclerosisBiological: Mesenchymal Stem Cells (MSC)Hadassah Medical OrganizationNULLCompleted18 Years65 YearsAll24Phase 1/Phase 2NULL
682NCT01759602
(ClinicalTrials.gov)
January 201329/12/2012C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica ExacerbationPhase 1b Study of C1-esterase Inhibitor (Cinryze) With Standard of Care for Acute Treatment of Neuromyelitis Optica ExacerbationsNeuromyelitis OpticaDrug: C1-esterase inhibitor (Cinryze)Michael LevyViroPharmaCompleted18 Years65 YearsAll10Phase 1United States
683NCT01606215
(ClinicalTrials.gov)
January 201321/5/2012Stem Cells in Rapidly Evolving Active Multiple SclerosisStem Cells in Rapidly Evolving Active Multiple SclerosisMultiple SclerosisDrug: Mesenchymal stem cells;Drug: PlaceboImperial College LondonNULLCompleted18 Years50 YearsAll21Phase 1/Phase 2United Kingdom
684NCT02249676
(ClinicalTrials.gov)
January 201315/9/2014Autologous Mesenchymal Stem Cells for the Treatment of Neuromyelitis Optica Spectrum DisordersAutologous Mesenchymal Stem Cells for the Treatment of Progressive and Refractory Neuromyelitis Optica Spectrum Disorders: an Open-label Phase 2a Proof-of-concept StudyDevic's Syndrome;Devic's Neuromyelitis Optica;Devic Syndrome;Devic's Disease;Devic DiseaseBiological: Autologous mesenchymal stem cellsTianjin Medical University General HospitalNULLCompleted18 Years80 YearsAll15Phase 2China
685NCT01753375
(ClinicalTrials.gov)
January 201317/12/2012Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple SclerosisRole of Vitamin D on the Relapse Rate of Multiple SclerosisMultiple SclerosisDietary Supplement: Vitamin D3;Dietary Supplement: PlaceboAlJohara M AlQuaiz, M.D.NULLNot yet recruiting18 Years55 YearsBoth200Phase 2Saudi Arabia
686NCT01665144
(ClinicalTrials.gov)
December 20, 20123/8/2012Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.Secondary Progressive Multiple SclerosisDrug: BAF312;Drug: PlaceboNovartis PharmaceuticalsNULLActive, not recruiting18 Years60 YearsAll1653Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;China;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Latvia;Lithuania;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Egypt
687EUCTR2012-003647-30-GB
(EUCTR)
20/12/201223/10/2012 A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) consisting of two parts: First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
2199 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
688EUCTR2012-003647-30-LV
(EUCTR)
13/12/201225/10/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
689EUCTR2012-003647-30-GR
(EUCTR)
11/12/201214/11/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Belarus;United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Albania;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany
690NCT01766063
(ClinicalTrials.gov)
December 6, 20127/12/2012Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on BetaferonBETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS PatientsMultiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY 86-5046)BayerNULLCompleted18 YearsN/AAll138Germany
691EUCTR2012-003647-30-SK
(EUCTR)
04/12/201220/02/2014A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2100Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
692NCT03778333
(ClinicalTrials.gov)
December 1, 201214/1/2015Mesenchymal Stem Cells for Progressive Multiple Sclerosis_SwedenMesenchymal Stem Cells for Progressive Multiple Sclerosis_SwedenAutologous Mesenchymal Stem Cells;Multiple SclerosisBiological: Autologous mesenchymal stem cellsKarolinska InstitutetNULLCompleted18 Years65 YearsAll7Phase 1Sweden
693NCT01728922
(ClinicalTrials.gov)
November 6, 20128/11/2012Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated SyndromeDose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome and Healthy Control Participants. An Exploratory Double Blind Placebo Randomised Controlled Study.Clinically Isolated Syndrome;Multiple SclerosisDietary Supplement: 5000IU vitamin D;Dietary Supplement: 10000IU vitamin D;Other: PlaceboUniversity College DublinUniversity of Dublin, Trinity College;St Vincent's University Hospital, IrelandCompleted18 Years55 YearsAll64Phase 1/Phase 2Ireland
694NCT01767493
(ClinicalTrials.gov)
November 201213/12/2012Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS PatientsAn 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 SclerosisMultiple SclerosisDrug: [18F]Florbetapir PET imagingInstitute for Neurodegenerative DisordersBiogenCompleted18 Years60 YearsAll19Phase 4United States
695NCT01679041
(ClinicalTrials.gov)
November 201229/8/2012High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior TreatmentA Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of TherapyMultiple SclerosisDrug: Alemtuzumab;Drug: Fludarabine;Drug: CyclophosphamideSeah Lim M.D.NULLTerminated18 Years60 YearsBoth1Phase 2United States
696NCT02137707
(ClinicalTrials.gov)
November 201212/5/2014Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With GilenyaAn Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 YearsMultiple Sclerosis-Relapsing-RemittingDrug: GilenyaMcGill UniversityNovartisCompleted18 Years65 YearsAll135Phase 4Canada
697NCT01743651
(ClinicalTrials.gov)
November 201228/11/2012Efficacy Study of Arbaclofen to Treat Spasticity in Multiple SclerosisA Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple SclerosisSpasticity;Multiple SclerosisDrug: arbaclofen;Drug: baclofen;Drug: PlaceboOsmotica Pharmaceutical US LLCNULLCompleted18 Years65 YearsAll353Phase 3United States;Russian Federation;Ukraine
698NCT01578330
(ClinicalTrials.gov)
October 201216/3/2012A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720A 12 -Month, Open-label, Multi-center Pilot Study to Explore the Health Outcomes of FTY720 in RRMS Patients Who Have Previously Been Treated With Other Disease Modifying Therapies (DMT)- FineMultiple Sclerosis;Relapsing-RemittingDrug: FingolimodNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll42Phase 4Turkey
699NCT01895439
(ClinicalTrials.gov)
October 201224/6/2013Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple SclerosisPhase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional TreatmentMultiple SclerosisBiological: Autologous Mesenchymal Stem CellsUniversity of JordanNULLCompleted18 Years65 YearsAll13Phase 1/Phase 2Jordan
700NCT01698086
(ClinicalTrials.gov)
October 201225/9/2012Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most? (MSVR3trial)Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most?Multiple Sclerosis;Balance;Fatigue;Eye MovementOther: Vestibular rehabilitation: balance and eye movement exercisesUniversity of Colorado, DenverNational Multiple Sclerosis SocietyCompleted18 Years60 YearsAll88N/AUnited States
701NCT01628393
(ClinicalTrials.gov)
September 18, 201222/6/2012Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients (Radiance Study)A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis PatientsRelapsing Multiple SclerosisDrug: RPC1063;Drug: placeboCelgeneNULLCompleted18 Years55 YearsAll258Phase 2/Phase 3United States;Belgium;Bulgaria;Georgia;Greece;Hungary;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine
702EUCTR2012-000957-30-CZ
(EUCTR)
11/09/201218/06/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® 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.NULLNot RecruitingFemale: yes
Male: yes
184Portugal;France;United States;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom
703NCT04371575
(ClinicalTrials.gov)
September 1, 201229/4/2020Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 PatientsSymptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - Clinical Characteristics, Neuroanatomical Abnormalities and Treatment EfficacyTrigeminal Neuralgia;Multiple Sclerosis;Pain, NeuropathicDrug: CarbamazepineStine Maarbjerg, MD PhDNULLCompletedN/AN/AAll60NULL
704NCT01706055
(ClinicalTrials.gov)
September 20127/9/2012Assessment 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 SclerosisBiological: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/AAll629N/APoland
705NCT01624714
(ClinicalTrials.gov)
September 201218/6/2012Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced SubjectsPhase I Trial Monitoring Efficacy and Safety in Treatment of Alemtuzumab Naive Subjects and Data Collecting and Monitoring of Alemtuzumab Experienced Subjects With Refractory Multiple SclerosisMultiple SclerosisDrug: Alemtuzumab;Drug: Alemtuzumab immunotherapySamuel Forrester Hunter, MD, PhDNULLActive, not recruiting18 Years75 YearsBoth60Phase 1United States
706NCT02442570
(ClinicalTrials.gov)
September 20121/5/2015A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple SclerosisA Phase IIa, Randomized, Double-blind, Placebo-controlled, Exploratory, Dose-ranging Study to Evaluate the Safety, Effectiveness and Pharmacokinetics of Three Courses of DC-TAB Treatment in Patients With Multiple SclerosisMultiple SclerosisBiological: recombinant human alpha B-crystallin;Other: Placebo comparatorDelta Crystallon BVNULLCompleted18 Years55 YearsBoth32Phase 2Bulgaria
707EUCTR2012-000957-30-BE
(EUCTR)
28/08/201201/06/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® 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: 14.1;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.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom
708NCT01705236
(ClinicalTrials.gov)
August 20, 201213/8/2012A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®A 3-year Multi-center Study to Describe the Long Term Changes of Optical Coherence Tomography (OCT) Parameters in Patients Under Treatment With Gilenya®Relapsing Remitting Multiple Sclerosis RRMSDrug: FingolimodNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll87Phase 4Germany;Switzerland
709NCT01633112
(ClinicalTrials.gov)
August 9, 201229/6/2012MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus CopaxoneA 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple Sclerosis (RRMS)Drug: fingolimod;Drug: glatiramer acetateNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll1064Phase 3United States;Argentina;Brazil;Canada;Chile;Mexico;Puerto Rico
710NCT01684761
(ClinicalTrials.gov)
August 201211/9/2012Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple SclerosisA Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple SclerosisAutoimmune Diseases of the Nervous System;Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Disease Progression;Brain AtrophyBiological: Tcelna;Biological: PlaceboOpexa Therapeutics, Inc.NULLCompleted18 Years60 YearsAll183Phase 2United States;Canada
711NCT01597297
(ClinicalTrials.gov)
August 201210/5/2012Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects With Multiple SclerosisMultiple SclerosisDrug: BIIB041 (PR Fampridine);Other: PlaceboBiogenNULLCompleted18 Years70 YearsAll132Phase 2Belgium;Canada;Italy;Netherlands;Sweden;United Kingdom
712NCT01639300
(ClinicalTrials.gov)
July 201210/7/2012Safety Study of GNbAC1 in Multiple Sclerosis PatientsRandomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1Multiple SclerosisBiological: GNbAC1;Biological: GNbAC1 placeboGeNeuro Innovation SASNULLCompleted18 Years65 YearsAll10Phase 2Switzerland
713NCT01600716
(ClinicalTrials.gov)
June 13, 201215/5/2012Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)Urinary Incontinence;Multiple Sclerosis;Neurogenic BladderBiological: OnabotulinumtoxinA;Drug: Placebo (Normal Saline)AllerganNULLCompleted18 YearsN/AAll144Phase 3United States;Belgium;Canada;Czechia;France;Poland;Portugal;Russian Federation;Czech Republic
714NCT01623596
(ClinicalTrials.gov)
June 8, 201218/6/2012Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Disease Modifying therapyNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll881Phase 4United States;Puerto Rico
715NCT01712945
(ClinicalTrials.gov)
June 201219/10/2012Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple SclerosisKeratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple SclerosisMultiple SclerosisDrug: Palifermin;Drug: AlemtuzumabCambridge University Hospitals NHS Foundation TrustNULLTerminated18 Months50 YearsAll40Phase 1/Phase 2United Kingdom
716NCT01656148
(ClinicalTrials.gov)
June 201231/7/2012FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of FampyraFampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of FampyraMultiple SclerosisDrug: Fampridine-SRUniversity of Southern DenmarkRegion of Southern Denmark;BiogenCompleted18 Years60 YearsAll108Phase 4Denmark
717EUCTR2011-004475-36-BG
(EUCTR)
19/05/201210/04/2012A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosisA Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment 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: DC-TAB
Product Code: DC-TAB
Other descriptive name: recombinant human alpha B-crystallin
Delta Crystallon B.V.NULLNot RecruitingFemale: yes
Male: yes
Phase 2Bulgaria
718NCT01641120
(ClinicalTrials.gov)
May 20126/7/2012Assessing Tolerability of Avonex Intramuscular InjectionsAssessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge NeedleMultiple SclerosisDrug: AvonexSaint Francis CareBiogenCompleted18 Years65 YearsAll20N/AUnited States
719NCT01491100
(ClinicalTrials.gov)
April 30, 201212/12/2011Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple SclerosisStudy Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 Years70 YearsAll1085Albania;Algeria;Argentina;Belgium;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Kazakhstan;Netherlands;Portugal;Saudi Arabia;Tunisia;Turkey;Bosnia and Herzegovina;Czech Republic;Jordan;Lebanon;Mexico;Poland;Syrian Arab Republic
720NCT01514370
(ClinicalTrials.gov)
April 30, 201217/1/2012Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1aProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW)Multiple SclerosisDrug: IFN beta 1a 44 mcg TIW;Drug: Curcumin;Drug: PlaceboMerck KGaA, Darmstadt, GermanyMerck Serono S.P.A., ItalyCompleted18 Years60 YearsAll80Phase 2Italy
721NCT01585298
(ClinicalTrials.gov)
April 29, 201223/4/2012STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: FTY720Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll6998Phase 4Germany
722EUCTR2011-005606-30-GB
(EUCTR)
25/04/201202/04/2012Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H).Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THY This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab.
MedDRA version: 14.1;Level: PT;Classification code 10058948;Term: Nephritis autoimmune;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10049046;Term: Autoimmune thyroiditis;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.1;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068004;Term: Autoimmune hyperthyroidism;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kepivance
Product Name: Kepivance
INN or Proposed INN: Palifermin
Trade Name: MabCampath
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Other descriptive name: anti-CD52 monoclonal antibody
Cambridge University Hospitals NHS Foundation Trust and University of CambridgeNULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
723NCT01585766
(ClinicalTrials.gov)
April 24, 20129/4/2012Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple SclerosisA Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple SclerosisMultiple Sclerosis, Relapsing FormsDrug: MEDI-551 30 MG-IV;Drug: MEDI-551 60 MG-SC;Drug: PLACEBO-IV-SC;Drug: MEDI-551 100 MG-IV;Drug: MEDI-551 300 MG-SC;Drug: MEDI-551 600 MG-IVMedImmune LLCNULLCompleted18 Years65 YearsAll56Phase 1United States;Poland;Spain;Ukraine;Czech Republic;United Kingdom
724NCT01480063
(ClinicalTrials.gov)
April 16, 201223/11/2011An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical PracticeA Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)Multiple SclerosisDrug: FampridineBiogenNULLCompletedN/AN/AAll4734Argentina;Canada;Czechia;France;Germany;Ireland;Israel;Lebanon;Netherlands;Norway;Portugal;Spain;United Arab Emirates;Australia;Belgium;Czech Republic;Denmark
725NCT01538225
(ClinicalTrials.gov)
April 201220/2/2012Neurophysiological Study of Sativex in Multiple Sclerosis (MS) SpasticityNeurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple SclerosisMultiple SclerosisDrug: Sativex®;Drug: PlaceboAlmirall, S.A.NULLCompleted18 YearsN/ABoth45Phase 3Italy
726NCT01490502
(ClinicalTrials.gov)
March 20126/12/2011Vitamin D Supplementation in Multiple SclerosisA Randomized Controlled Trial of Vitamin D Supplementation in Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Vitamin D3Johns Hopkins UniversityOregon Health and Science University;University of California, San Francisco;Washington University School of Medicine;Icahn School of Medicine at Mount Sinai;University of Pennsylvania;Yale University;The Cleveland Clinic;University of Rochester;Stanford University;University of Virginia;Swedish Medical Center;Anne Arundel Health System Research Institute;Columbia University;University of Massachusetts, Worcester;Dignity HealthCompleted18 Years50 YearsAll172Phase 3United States
727NCT01578785
(ClinicalTrials.gov)
March 201213/3/2012An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous InjectionRelapsing-Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: PlaceboTeva Pharmaceutical IndustriesNULLTerminated18 Years55 YearsAll178Phase 3United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Greece;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Montenegro;Poland;Romania;Russian Federation;Serbia;Ukraine;Lithuania
728NCT01485003
(ClinicalTrials.gov)
February 7, 20121/12/2011Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative ParticipantsA Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative PatientsRelapsing-Remitting Multiple SclerosisBiological: natalizumabBiogenNULLCompleted18 Years65 YearsAll231United States
729NCT01433250
(ClinicalTrials.gov)
February 201226/8/2011A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple SclerosisAn Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: AIN457Novartis PharmaceuticalsNULLCompleted18 Years55 YearsAll39Phase 2Czech Republic;Russian Federation;Ukraine
730NCT01480076
(ClinicalTrials.gov)
February 201223/11/2011Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple SclerosisAn Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple SclerosisMultiple SclerosisDrug: FampridineBiogenNULLCompleted18 Years75 YearsAll901Phase 4Australia;Belgium;Denmark;France;Germany;Italy;Netherlands;Portugal;United Kingdom;United States
731NCT01497262
(ClinicalTrials.gov)
February 20125/12/2011Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisA 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll162Phase 3Argentina;Brazil;Colombia;Jordan;Malaysia;Mexico;Panama;Peru;Costa Rica
732NCT01569451
(ClinicalTrials.gov)
February 201230/3/2012Comparison of Rituximab Induction Therapy Followed by Glatiramer AcetateA Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Rituximab;Drug: Glatiramer Acetate;Other: PlaceboUniversity of Colorado, DenverRocky Mountain MS Research Group, LLCCompleted18 Years55 YearsAll53Phase 2United States
733NCT02305264
(ClinicalTrials.gov)
February 201225/1/2013Imaging of Intracerebral Inflammation in MSImaging of Intracerebral Inflammation in the Progressive Phase of Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary ProgressiveDrug: 18F-DPA-714 and 18F-FDGAssistance Publique - Hôpitaux de ParisNULLRecruiting18 Years65 YearsAll65N/AFrance
734NCT04289675
(ClinicalTrials.gov)
January 1, 201227/12/2019Multiple Sclerosis: Chi3L1 and Treatment EfficacyChi3L1: A Marker of Efficacy of Platform Treatments in Relapsing-onset Multiple Sclerosis: A Prognostic Study on Existing Clinical Data and Biological SamplesMultiple SclerosisDrug: Interferon-BetaCentral Hospital, Nancy, FranceNULLCompleted18 Years55 YearsAll63NULL
735NCT01535664
(ClinicalTrials.gov)
January 20127/2/2012An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MSMultiple SclerosisOther: Withdrawal of dalfampridine-ER 10mgAcorda TherapeuticsPrometrika, LLC;BCS Consulting, Inc.Completed18 Years70 YearsAll20United States
736NCT01964547
(ClinicalTrials.gov)
January 201215/10/2013A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis PatientsA Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study of the Effect of Long-term Treatment With Sativex on Cognitive Function and Mood of Patients With Spasticity Due to Multiple SclerosisMultiple Sclerosis;SpasticityDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll121Phase 4Czech Republic
737NCT01517282
(ClinicalTrials.gov)
January 201210/1/2012Phase Ib Study to Evaluate MOR103 in Multiple SclerosisA Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety and Pharmacokinetics of MOR103, a Human Antibody to GM-CSF, in Patients With Multiple SclerosisMultiple SclerosisBiological: MOR103;Other: PlaceboMorphoSys AGNULLCompleted18 Years60 YearsAll32Phase 1/Phase 2Germany;Poland;United Kingdom
738NCT01534182
(ClinicalTrials.gov)
January 20128/2/2012Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Interferon beta - 1a (IFN);Drug: Glatiramer acetate (GA)Novartis PharmaceuticalsNULLCompleted18 Years65 YearsAll298Phase 4Russian Federation
739NCT01498887
(ClinicalTrials.gov)
December 24, 201119/12/2011Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying TherapyA Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: Fingolimod (FTY720)Novartis PharmaceuticalsNULLCompleted18 Years50 YearsAll347Phase 4Australia;Spain
740NCT02967380
(ClinicalTrials.gov)
December 14, 201113/9/2015Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain MetastasesDynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial LesionsAdult Anaplastic (Malignant) Meningioma;Adult Anaplastic Astrocytoma;Adult Anaplastic Ependymoma;Adult Anaplastic Oligodendroglioma;Adult Brain Stem Glioma;Adult Choroid Plexus Neoplasm;Adult Diffuse Astrocytoma;Adult Ependymoblastoma;Adult Ependymoma;Adult Giant Cell Glioblastoma;Adult Glioblastoma;Adult Gliosarcoma;Adult Grade II Meningioma;Adult Medulloblastoma;Adult Mixed Glioma;Adult Oligodendroglioma;Adult Papillary Meningioma;Adult Pineal Gland Astrocytoma;Adult Pineoblastoma;Adult Primary Melanocytic Lesion of Meninges;Adult Supratentorial Primitive Neuroectodermal Tumor;Malignant Adult Intracranial Hemangiopericytoma;Metastatic Malignant Neoplasm in the Brain;Multiple Sclerosis;Recurrent Adult Brain NeoplasmProcedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging;Drug: Gadobenate Dimeglumine;Drug: Gadobutrol;Radiation: Gadopentetate DimeglumineUniversity of Southern CaliforniaNational Cancer Institute (NCI)Terminated18 YearsN/AAll14N/AUnited States
741NCT01377870
(ClinicalTrials.gov)
December 201119/6/2011Evaluation of Autologous Mesenchymal Stem Cell Transplantation (Effects and Side Effects) in Multiple SclerosisEffect and Side Effect of Mesenchymal Stem Cell in Multiple SclerosisMultiple SclerosisBiological: intravenous injection of mesenchymal stem cells;Biological: injection of cell free mediaRoyan InstituteNULLCompleted18 Years55 YearsAll22Phase 1/Phase 2Iran, Islamic Republic of
742NCT02006160
(ClinicalTrials.gov)
December 20116/6/2012Effects of Dalfampridine on Cognition in Multiple SclerosisEffects of Dalfampridine on Cognition in Multiple SclerosisMultiple SclerosisDrug: dalfampridine;Drug: placeboState University of New York at BuffaloNULLCompleted18 Years60 YearsAll61Phase 2/Phase 3United States
743NCT01440062
(ClinicalTrials.gov)
December 201119/9/2011Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)Phase II Study of Efficacy of Vitamin D Supplementation in Multiple SclerosisMultiple SclerosisDrug: Verum arm receiving Vitamin D oil;Drug: low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second dayCharite University, Berlin, GermanyNeuroCure Clinical Research Center, Charite, BerlinTerminated18 Years65 YearsAll55Phase 2Germany
744NCT01943526
(ClinicalTrials.gov)
November 30, 201112/9/2013Ireland Natalizumab (TYSABRI) Observational ProgramIreland Natalizumab (TYSABRI®) Observational Program (iTOP)Relapsing-Remitting Multiple SclerosisBiological: natalizumabBiogenNULLCompletedN/AN/AAll191Ireland
745NCT01457924
(ClinicalTrials.gov)
November 1, 201120/10/2011Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Ofatumumab 3mg;Drug: Ofatumumab 30mg;Drug: Ofatumumab 60mg;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years55 YearsAll232Phase 2United States;Bulgaria;Canada;Czechia;Denmark;Germany;Italy;Netherlands;Norway;Russian Federation;Spain;Czech Republic
746NCT01436643
(ClinicalTrials.gov)
November 201116/9/2011Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With DepressionA 21-week, Multicenter, Open Label Study to Evaluate the Safety and Tolerability Profile of the Combination of a SSRI or SNRI Antidepressive Therapy With Oral Fingolimod in the Treatment of RRMS Patients With Mild to Moderate DepressionDepression;Relapsing-remitting Multiple SclerosisDrug: Venlafaxine;Drug: Fluoxetine;Drug: Citalopram;Drug: FingolimodNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll54Phase 4Germany
747NCT01462318
(ClinicalTrials.gov)
November 201114/7/2011An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple SclerosisA Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: Midazolam;Other: Caffeine;Drug: S-warfarin;Other: Vitamin K;Drug: Omeprazole;Drug: Dextromethorphan;Biological: BIIB019 (Daclizumab)BiogenNULLCompleted18 Years65 YearsAll133Phase 3United States;Czech Republic;Hungary;Poland;Russian Federation
748EUCTR2011-002258-30-IT
(EUCTR)
04/10/201110/04/2012CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF Sativex in relieving pain PEOPLE AFFECTED BY MULTIPLE SCLEROSISNEUROPHYSIOLOGIC STUDY AIMED AT EVALUATING ON EFFECT OF SATIVEX® ON SPASTICITY IN PROGRESSIVE MULTIPLE SCLEROSIS - M/SATIVX/01 Subject of both male and female gender affected by Secondary-Progressive (SP) or Primary-Progressive (PP) MS
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]
Trade Name: SATIVEX
INN or Proposed INN: CANNABIDIOL
INN or Proposed INN: DELTA-9-TETRAHYDROCANNABINOL
ALMIRALL PRODESFARMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
749NCT01489254
(ClinicalTrials.gov)
October 20118/12/2011Efficacy and Safety of GTR in Comparison to Copaxone®Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment EffectsMultiple SclerosisDrug: Glatiramer Acetate (GTR);Drug: Glatiramer Acetate (Copaxone®);Drug: PlaceboSynthon BVNULLCompleted18 Years55 YearsAll794Phase 3United States;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Ukraine;United Kingdom;Greece;Kazakhstan
750NCT01412333
(ClinicalTrials.gov)
September 20, 20118/8/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple SclerosisA 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 SclerosisRelapsing Multiple SclerosisDrug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placeboHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll835Phase 3United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic;Morocco
751NCT01416181
(ClinicalTrials.gov)
September 13, 201121/7/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label ExtensionSecondary Progressive Multiple SclerosisDrug: natalizumab;Drug: PlaceboBiogenNULLTerminated18 Years58 YearsAll889Phase 3United States;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic
752NCT01435993
(ClinicalTrials.gov)
September 8, 201125/8/2011Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple SclerosisA Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis.Multiple Sclerosis, Relapsing-RemittingDrug: GSK1223249;Other: Saline placeboGlaxoSmithKlineNULLTerminated18 Years60 YearsAll3Phase 1Italy;Norway;Germany
753EUCTR2011-001442-15-ES
(EUCTR)
01/09/201107/07/2011Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
600Hungary;Germany;Switzerland;France;Italy;Austria;Sweden;Israel;Finland;United Kingdom;Czech Republic;Spain;Greece
754NCT01324232
(ClinicalTrials.gov)
September 201123/3/2011Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple SclerosisA Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple SclerosisCentral Neuropathic Pain;Multiple SclerosisDrug: AVP-923;Drug: PlaceboAvanir PharmaceuticalsNULLCompleted18 Years85 YearsAll200Phase 2United States;Argentina;Czechia;Poland;Spain;Czech Republic;Germany;United Kingdom
755NCT01444300
(ClinicalTrials.gov)
September 201120/9/2011Dalfampridine for Imbalance in Multiple SclerosisDalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot StudyMultiple Sclerosis;FatigueDrug: Dalfampridine;Drug: PlaceboOregon Health and Science UniversityAcorda TherapeuticsCompleted20 Years59 YearsAll24Phase 2United States
756NCT01450124
(ClinicalTrials.gov)
September 201118/9/2011Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA)Safety, Tolerability And Mechanism Of Action Of Boswellic Acids In Multiple Sclerosis and Clinically Isolated Syndrome: A MRI-Controlled, Multicenter, Baseline-To-Treatment, 32-Weeks, Open-Label, Phase IIa TrialRelapsing Remitting Multiple SclerosisDrug: Boswellic acids (BOSWELAN)Universitätsklinikum Hamburg-EppendorfNULLCompleted18 Years65 YearsAll29Phase 2Germany
757NCT01499667
(ClinicalTrials.gov)
September 201118/8/2011Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to FingolimodA 32-week, Patient- and Rater-blinded, Randomized, Multi-center, Parallel-group Study to Evaluate Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis Transferred From Previous Treatment With Natalizumab to Fingolimod (FTY720)Relapsing Remitting Multiple Sclerosis (RRMS)Drug: Fingolimod;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll142Phase 3Australia;Austria;Czech Republic;Finland;Germany;Greece;Hungary;Israel;Italy;Spain;Switzerland
758NCT01403376
(ClinicalTrials.gov)
September 201114/7/2011Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on TeriflunomideStudy 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 ReferenceMultiple SclerosisDrug: teriflunomide;Drug: Interferon-ß-1;Biological: Influenza vaccineSanofiNULLCompleted18 Years59 YearsAll128Phase 2Austria;Canada;Germany;Russian Federation;Ukraine
759NCT01247324
(ClinicalTrials.gov)
August 31, 201123/11/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple SclerosisA 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 SclerosisRelapsing Multiple SclerosisDrug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placeboHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll821Phase 3Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;United States;Czech Republic;Morocco;New Zealand;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France
760NCT01442194
(ClinicalTrials.gov)
August 1, 201121/8/2011Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying TherapiesLong-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying TherapyMultiple SclerosisDrug: other disease-modifying therapy;Drug: FingolimodNovartis PharmaceuticalsNULLCompletedN/AN/AAll3076United States;Argentina;Australia;Canada;Chile;Mexico;Puerto Rico
761NCT01405820
(ClinicalTrials.gov)
August 201114/7/2011Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: natalizumab IV;Drug: natalizumab SC;Drug: IV Placebo;Drug: SC PlaceboBiogenNULLCompleted18 Years55 YearsAll290Phase 2Belgium;France;Germany;Italy;Spain
762NCT01433497
(ClinicalTrials.gov)
August 201112/9/2011Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple SclerosisA 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple SclerosisMultiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Relapse FreeDrug: Masitinib;Drug: PlaceboAB ScienceNULLCompleted18 Years75 YearsAll656Phase 3Bulgaria;France;Germany;Greece;Poland;Romania;Spain;United States
763NCT01417312
(ClinicalTrials.gov)
July 201115/8/2011Metabolic Effects of a Green Tea Extract in Multiple Sclerosis PatientsMultiple Sclerosis, Relapsing-RemittingDietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG);Dietary Supplement: PlaceboCharite University, Berlin, GermanyNULLCompleted20 Years60 YearsAll20N/AGermany
764NCT01451723
(ClinicalTrials.gov)
July 201111/10/2011Safety and Neuroprotective Effects of Polyphenon E in MS; Phase IIPhase 2 Randomized Placebo Controlled Trial of Polyphenon E in MSMultiple SclerosisDrug: Polyphenon E;Other: PlaceboLouisiana State University Health Sciences Center in New OrleansNational Center for Complementary and Integrative Health (NCCIH)Terminated18 Years60 YearsAll11Phase 2United States
765NCT01395316
(ClinicalTrials.gov)
June 201113/7/2011Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple SclerosisAlemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: AlemtuzumabUniversity of ChicagoGenzyme, a Sanofi CompanyCompleted18 Years50 YearsAll8Phase 4NULL
766NCT01259388
(ClinicalTrials.gov)
May 201110/12/2010A Pilot Study of Lithium in Progressive Multiple SclerosisA Pilot Trial of Lithium in Progressive Multiple SclerosisMultiple SclerosisDrug: Lithium CarbonateVA Office of Research and DevelopmentNULLCompleted30 Years65 YearsAll23Phase 1/Phase 2United States
767NCT01359566
(ClinicalTrials.gov)
May 201122/5/2011Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple SclerosisA Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple SclerosisMultiple SclerosisDrug: Arbaclofen placarbil 15 mg BID;Drug: Placebo;Drug: Arbaclofen placarbil 30 mg BID;Drug: Arbaclofen placarbil 45 mg BIDXenoPort, Inc.NULLCompleted18 Years70 YearsAll228Phase 3United States
768NCT01333501
(ClinicalTrials.gov)
May 20118/4/2011Fingolimod Versus Interferon Beta 1b in Cognitive SymptomsA 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 AtrophyMultiple SclerosisDrug: Fingolimod;Drug: Interferon beta 1bNovartis PharmaceuticalsNULLCompleted18 Years50 YearsAll151Phase 4Germany;Italy
769NCT01357980
(ClinicalTrials.gov)
May 201117/5/2011Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple SclerosisA Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.Detrusor Muscle HyperactivityBiological: Botulinum toxin type A;Drug: PlaceboIpsenNULLCompleted18 Years70 YearsAll47Phase 2Czechia;France;Germany;Italy;Poland;Austria;Czech Republic
770NCT01333358
(ClinicalTrials.gov)
May 20118/4/2011Evaluating Alemtuzumab as a Treatment in Stabilizing Neurocognitive Function In Relapsing Remitting Multiple Sclerosis PatientsPhase III A Prospective, Longitudinal, Rater-blinded Single-arm Study to Evaluate Alemtuzumab as an Effective Treatment in Stabilizing Overall Neurocognitive Function in RRMS Subjects at Specified TimepointsMultiple SclerosisDrug: AlemtuzumabCentral Texas Neurology ConsultantsGenzyme, a Sanofi CompanyNot yet recruitingN/AN/ABoth30Phase 3NULL
771NCT01317004
(ClinicalTrials.gov)
May 201115/3/2011Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy ChangeA 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Standard MS DMTNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll61Phase 4Italy
772NCT01337986
(ClinicalTrials.gov)
May 201113/4/2011Ampyra for Optic Neuritis in Multiple SclerosisDalfampridine After Optic Neuritis to Improve Visual Function in Multiple SclerosisMultiple Sclerosis;Optic NeuritisDrug: Dalfampridine/Placebo;Drug: Placebo/DalfampridineWashington University School of MedicineAcorda TherapeuticsCompleted18 Years55 YearsAll53Phase 2/Phase 3United States
773NCT01332019
(ClinicalTrials.gov)
April 201124/3/2011Long-Term Safety and Efficacy Study of Peginterferon Beta-1aA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: peginterferon beta-1aBiogenNULLCompleted18 Years65 YearsAll1077Phase 3United States;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Estonia;France;Georgia;Germany;Greece;India;Latvia;Mexico;Netherlands;New Zealand;Peru;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
774EUCTR2010-023560-40-SE
(EUCTR)
23/03/201121/12/2010Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST Relapsing-remitting multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Sendoxan
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Trade Name: Solu-Medrol
Uppsala l?ns landstingNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United States;Canada;Brazil;Sweden
775NCT01194570
(ClinicalTrials.gov)
March 2, 201128/8/2010A Study of Ocrelizumab in Participants With Primary Progressive Multiple SclerosisA Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Other: PlaceboHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll732Phase 3United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czechia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Lithuania;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Uruguay;Czech Republic;Denmark;Turkey
776NCT01307332
(ClinicalTrials.gov)
March 201126/1/2011Advanced MRI Measures of Repair in Alemtuzumab Treated PatientsAdvanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated PatientsRelapsing Remitting Multiple SclerosisDrug: MabCampath-1hUniversity of British ColumbiaGenzyme, a Sanofi CompanyCompleted18 Years50 YearsAll27Phase 3Canada
777NCT01328379
(ClinicalTrials.gov)
March 201129/3/2011Study of Fampridine-ER Tablets in Patients With Multiple SclerosisDouble-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Doses of Oral Dalfampridine Extended Release Tablets (5 mg and 10 mg Twice Daily) in Patients With Multiple SclerosisMultiple SclerosisDrug: Dalfampridine-ER 5mg;Drug: Dalfampridine-ER 10mg;Other: PlaceboAcorda TherapeuticsNULLCompleted18 Years70 YearsAll430Phase 3United States
778EUCTR2009-010788-18-IT
(EUCTR)
03/02/201131/05/2011An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - NDAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND Relapsing Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: MABCAMPATH
INN or Proposed INN: Alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Czech Republic;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
779NCT03822858
(ClinicalTrials.gov)
February 201124/1/2019Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple SclerosisAutologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered IntrathecallyMultiple SclerosisDrug: Intrathecal MSC-NP injectionTisch Multiple Sclerosis Research Center of New YorkNULLAvailable18 Years70 YearsAllUnited States
780NCT01285401
(ClinicalTrials.gov)
February 201126/1/2011Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® TreatmentA 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 44mg Tiw of Rebif®Relapsing-Remitting Multiple SclerosisDrug: VigantOL oil plus interferon beta-1a (Rebif);Drug: Placebo plus interferon beta-1a (Rebif);Biological: Interferon beta-1a (Rebif®) aloneMerck KGaANULLCompleted18 Years55 YearsAll260Phase 2Austria;Denmark;Estonia;Finland;Germany;Italy;Latvia;Lithuania;Netherlands;Norway;Portugal;Switzerland;Belgium;Hungary
781NCT02073474
(ClinicalTrials.gov)
February 201121/2/2014An 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 PainDrug: Sativex®GW Pharmaceuticals Ltd.NULLCompletedN/AN/AAll978N/ANULL
782NCT01454791
(ClinicalTrials.gov)
January 20119/8/2011Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer AcetateDiclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover TrialMultiple SclerosisDrug: diclofenac sodium topical gel;Other: PlaceboBrown, Theodore R., M.D., MPHTeva Neuroscience, Inc.Completed18 YearsN/AAll40Phase 4United States
783NCT01252355
(ClinicalTrials.gov)
January 201130/11/2010Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-betaA 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-betaMultiple Sclerosis RelapseDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-beta (IFN-beta)SanofiNULLTerminated18 Years55 YearsAll534Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Lithuania;Netherlands;Norway;Portugal;Russian Federation;Slovakia;Spain;Sweden;Tunisia;United Kingdom;Turkey
784NCT01455220
(ClinicalTrials.gov)
January 201110/10/2011The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple SclerosisThe Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple SclerosisMultiple SclerosisDrug: Tysabri ® (Natalizumab)University of South FloridaNULLCompleted18 Years60 YearsAll45N/AUnited States
785NCT01466322
(ClinicalTrials.gov)
December 22, 20103/11/2011A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers.An Open-label, Randomised, Crossover Study to Assess the Relative Bioavailability of Different 2mg Formulations of GSK2018682(S1P1 Agonist) in Healthy VolunteersMultiple Sclerosis, Relapsing-RemittingDrug: GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed stateGlaxoSmithKlineNULLCompleted18 Years55 YearsAll16Phase 1Australia
786EUCTR2009-010788-18-AT
(EUCTR)
21/12/201017/08/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study 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: MabCampath
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Serbia;United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
787EUCTR2010-020338-25-ES
(EUCTR)
20/12/201017/09/2010Estudio 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 - OratorioEstudio 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 RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria
788NCT01228266
(ClinicalTrials.gov)
December 201025/10/2010Mesenchymal Stem Cell Transplantation in MSAutologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II StudyMultiple SclerosisBiological: autologous mesenchymal stem cellsAlbert SaizInstituto de Salud Carlos IIITerminated18 Years50 YearsBoth9Phase 2Spain
789EUCTR2009-010788-18-SE
(EUCTR)
29/11/201012/08/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: alemtuzumab
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
790EUCTR2009-012989-30-AT
(EUCTR)
25/11/201014/12/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
791NCT01356940
(ClinicalTrials.gov)
November 201018/5/2011A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple SclerosisA Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple SclerosisMultiple SclerosisDrug: dalfampridine ER;Drug: placeboBrown, Theodore R., M.D., MPHAcorda TherapeuticsCompleted18 Years75 YearsAll43Phase 4United States
792NCT01440101
(ClinicalTrials.gov)
November 201014/4/2011Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B)Multiple SclerosisDrug: Natalizumab (BG00002);Drug: PlaceboBiogenNULLCompleted18 Years65 YearsAll106Phase 2/Phase 3Japan;China
793NCT00939549
(ClinicalTrials.gov)
November 201014/7/2009High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisPhase II Study of High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Cyclophosphamide/Glatiramer acetateJohns Hopkins UniversityNULLWithdrawn18 Years70 YearsAll0Phase 2United States
794NCT02937285
(ClinicalTrials.gov)
November 20109/9/2016National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple SclerosisNational Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Beta-1a (REBIF 44mg 3 Times / Week) Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple SclerosisMultiple SclerosisDrug: Interferon beta 1a;Drug: MitoxantroneRennes University HospitalNULLActive, not recruiting18 Years50 YearsAll266Phase 3France
795NCT01236534
(ClinicalTrials.gov)
November 20104/11/2010Lubiprostone in Patients With Multiple Sclerosis Associated ConstipationSingle-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated ConstipationMultiple Sclerosis;ConstipationDrug: Lubiprostone;Drug: PlaceboUniversity of RochesterTakedaCompleted18 YearsN/AAll21Phase 4United States
796EUCTR2010-020515-37-ES
(EUCTR)
20/10/201002/08/2010Estudio 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 múltipleEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
797NCT01431937
(ClinicalTrials.gov)
October 10, 201011/8/2011Assessment of Repeat Ascending Doses of GSK2018682 in Healthy VolunteersA Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Ascending Doses of GSK2018682 (S1P1 Agonist) in Healthy VolunteersMultiple Sclerosis, Relapsing-RemittingDrug: GSK2018682;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years55 YearsAll40Phase 1Australia
798NCT01188811
(ClinicalTrials.gov)
October 201025/8/2010Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)Lipoic Acid for Neuroprotection in Secondary Progressive MSMultiple Sclerosis, Chronic ProgressiveDrug: lipoic acid;Drug: PlaceboVA Office of Research and DevelopmentOregon Health and Science UniversityCompleted40 Years70 YearsAll54Phase 2/Phase 3United States
799NCT01226745
(ClinicalTrials.gov)
October 201019/10/2010Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: ONO-4641EMD SeronoMerck KGaA;Ono Pharmaceutical Co. LtdTerminated18 Years55 YearsAll340Phase 2United States;Belgium;Canada;Czech Republic;Germany;Greece;Japan;Poland;Russian Federation;Spain;Ukraine
800NCT01166178
(ClinicalTrials.gov)
October 201019/7/2010Zoledronic Acid in MS-patients With OsteoporosisA 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment PhaseOsteoporosis;Multiple SclerosisDrug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combinationNovartisNULLTerminated18 Years75 YearsAll29Phase 3Germany
801NCT01244139
(ClinicalTrials.gov)
October 201018/11/2010Safety Study of BIIB033 in Subjects With Multiple SclerosisA Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: BIIB033;Drug: PlaceboBiogenNULLCompleted18 Years60 YearsAll47Phase 1United States
802NCT01416155
(ClinicalTrials.gov)
October 201024/3/2011Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple SclerosisA Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: natalizumabBiogenNULLCompleted18 Years65 YearsAll97Phase 2Japan;China
803NCT01381354
(ClinicalTrials.gov)
October 201026/5/2011Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)Multiple SclerosisOther: Progressive exercise;Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV;Other: Modified paleolithic diet;Dietary Supplement: Omega 3 fatty acids;Dietary Supplement: Full Spectrum vitamin;Dietary Supplement: Essential - hydroxytyrosol;Dietary Supplement: Maltodextrin fiber supplement;Dietary Supplement: Mineral boost (magnesium);Dietary Supplement: Niacinamide;Dietary Supplement: Methyl B12;Dietary Supplement: Taurine;Dietary Supplement: creatine;Dietary Supplement: thiamine;Dietary Supplement: riboflavin;Dietary Supplement: N acetylcysteine;Dietary Supplement: alpha lipoic acid;Dietary Supplement: L acetyl carnitine;Dietary Supplement: methyl folate;Dietary Supplement: coenzyme Q;Behavioral: meditation;Behavioral: self massage;Behavioral: learning;Dietary Supplement: Coconut oilUniversity of IowaDirect MS Canada;DJO Incorporated;Pinnaclife Inc.;TZ Press, LLCCompleted18 Years65 YearsAll38Phase 1United States
804EUCTR2009-010788-18-ES
(EUCTR)
27/09/201008/01/2010Protocolo 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
805NCT01201356
(ClinicalTrials.gov)
September 13, 201010/9/2010Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple SclerosisA 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 SclerosisRelapsing Forms of Multiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll4125Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;Egypt;Estonia;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Jordan;Korea, Republic of;Malaysia;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom;Costa Rica;Czech Republic
806NCT01202227
(ClinicalTrials.gov)
September 201031/8/2010An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic PainAn 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;PainDrug: pregabalinPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll104Phase 3Japan
807NCT01212094
(ClinicalTrials.gov)
September 201029/9/2010Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)Multiple SclerosisDrug: Rituximab;Other: normal salineNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 Years65 YearsAll44Phase 1/Phase 2United States
808NCT01116427
(ClinicalTrials.gov)
September 20103/5/2010A Cooperative Clinical Study of Abatacept in Multiple SclerosisA Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: abatacept;Drug: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Completed18 Years65 YearsAll65Phase 2United States;Canada
809NCT01185821
(ClinicalTrials.gov)
August 30, 201019/8/2010Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple SclerosisA Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BAF312Novartis PharmaceuticalsNULLCompleted18 Years56 YearsAll185Phase 2United States;Canada;Finland;Germany;Hungary;Italy;Norway;Poland;Russian Federation;Spain;Switzerland;Turkey
810NCT01216072
(ClinicalTrials.gov)
August 20107/9/2010A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple SclerosisA 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)Relapsing Forms of Multiple SclerosisDrug: Fingolimod;Drug: Standard MS DMTsNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll1053Phase 4United States;Canada;Puerto Rico
811NCT00997438
(ClinicalTrials.gov)
August 201016/10/2009Defining the Anti-inflammatory Role of Lipoic Acid in Multiple SclerosisDefining the Anti-inflammatory Role of Lipoic Acid in Multiple SclerosisMultiple SclerosisDietary Supplement: Lipoic AcidPortland VA Medical CenterOregon Health and Science UniversityCompleted18 YearsN/AAll69Phase 1United States
812NCT01199861
(ClinicalTrials.gov)
August 20109/9/2010Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS)Relapsing Multiple SclerosisDrug: Fingolimod;Drug: Placebo;Biological: Seasonal influenza vaccine;Biological: Tetanus toxoid vaccineNovartisNULLCompleted18 Years55 YearsAll138Phase 3Belgium;Canada;Finland;France;Guatemala;Poland;Spain;Switzerland;United Kingdom;Austria
813NCT01207648
(ClinicalTrials.gov)
July 201021/9/2010Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)Retrospective Cohort Study of Rebif® Use in Pediatric MS PatientsMultiple SclerosisDrug: Rebif®EMD SeronoNULLCompletedN/A18 YearsAll307N/AUnited States;Argentina;Canada;France;Italy;Russian Federation;Tunisia;Venezuela
814NCT01171209
(ClinicalTrials.gov)
July 20108/7/2010REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis PatientsREsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis PatientsMultiple SclerosisDrug: Interferon-beta and human leukocyte Interferon-aMelinda MagyariUniversity of CopenhagenCompleted18 Years55 YearsBoth10Phase 2Denmark
815NCT01167426
(ClinicalTrials.gov)
July 201020/7/2010Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) PatientsAn Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method.Multiple SclerosisDrug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mLTeva Neuroscience, Inc.NULLCompleted18 YearsN/AAll148Phase 3United States
816NCT01085318
(ClinicalTrials.gov)
June 30, 201010/3/2010Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot TrialA Twenty-four Week, Two Arm, Pilot Trial to Evaluate Remyelination/ Demyelination, Gray Matter Volume and Iron Deposition in the Central Nervous System (CNS) and Immune Status of Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) Treated With Rebif® 44 mcg Subcutaneously (sc) Three Times a Week (Tiw) Compared to a Healthy Control GroupMultiple SclerosisDrug: RebifEMD SeronoNULLCompleted18 Years65 YearsAll38Phase 4United States
817EUCTR2009-012500-11-ES
(EUCTR)
24/06/201012/04/2010Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.)Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) Esclerosis Múltiple recidivante-remitente
MedDRA version: 11;Level: PT;Classification code 10063399;Term: Esclerosis múltiple remitente-recurrente
Product Name: DACLIZUMAB HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
818NCT01067521
(ClinicalTrials.gov)
June 22, 201010/2/2010A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind DesignA Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind DesignRelapsing Remitting Multiple SclerosisDrug: Glatiramer acetate (GA);Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years55 YearsAll1404Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Poland;Romania;Russian Federation;South Africa;Ukraine;United Kingdom;Czech Republic;Turkey
819EUCTR2009-010788-18-NL
(EUCTR)
07/06/201018/09/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study 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: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: N.A.
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Serbia;United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden
820NCT01149525
(ClinicalTrials.gov)
June 201021/6/2010Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple SclerosisA Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple SclerosisMultiple SclerosisDrug: L-Carnitine;Drug: PlaceboUniversity Hospital, BordeauxNULLCompleted18 YearsN/AAll59Phase 3France
821NCT01144052
(ClinicalTrials.gov)
June 201011/6/2010Natalizumab De-escalation With Interferon Beta-1bDe-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: interferon beta-1b;Drug: NatalizumabClaudio GobbiOspedale Civico, LuganoCompleted18 Years60 YearsAll19Phase 4Switzerland
822NCT01156311
(ClinicalTrials.gov)
June 20101/7/2010BG00012 Phase 2 Combination Study in Participants With Multiple SclerosisAn Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNß) or Glatiramer Acetate (GA)Relapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: dimethyl fumarateBiogenNULLCompleted18 Years55 YearsAll108Phase 2United States
823NCT01047319
(ClinicalTrials.gov)
May 27, 20108/1/2010A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple SclerosisA Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: LaquinimodTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminatedN/AN/AAll1047Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Macedonia, The Former Yugoslav Republic of;Puerto Rico
824EUCTR2009-015556-15-ES
(EUCTR)
24/05/201024/03/2010Estudio 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 - SURPASSEstudio 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
825NCT01387217
(ClinicalTrials.gov)
May 21, 201014/4/2011GSK2018682 FTIH in Healthy VolunteersA Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy VolunteersMultiple SclerosisDrug: GSK2018682;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years55 YearsAll27Phase 1Australia
826EUCTR2009-011470-15-ES
(EUCTR)
18/05/201022/03/2010Estudio de extensión del estudio AC-058B201, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, para evaluar la seguridad, tolerabilidad, y eficacia a largo plazo de 10, 20, y 40 mg/día de ACT-128800, un agonista oral de los receptores S1P1, en pacientes con esclerosis múltiple recurrente-remitente - Esclerosi Múltiple Recurrente-Remitente
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Hungary;Finland;Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;Spain;Italy;Austria;Poland;Sweden
827NCT01143441
(ClinicalTrials.gov)
May 13, 201011/6/2010Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis (MS)Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis (MS)Multiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingBiological: DAC-HYPNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 Years60 YearsAll48Phase 1United States
828NCT01093326
(ClinicalTrials.gov)
May 12, 201024/3/2010Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple SclerosisMulticenter, 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 SclerosisMultiple SclerosisDrug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mgActelionNULLActive, not recruiting18 Years55 YearsAll353Phase 2Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Austria;Bulgaria;Canada;Czechia;Finland;France;United States;Czech Republic;Italy
829NCT01064401
(ClinicalTrials.gov)
May 201026/1/2010Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ß 1a in Participants With Relapsing-Remitting Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon ß 1a) in Patients With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisBiological: BIIB019 (Daclizumab High Yield Process);Drug: Interferon beta-1a Placebo;Biological: Interferon beta-1a;Drug: Daclizumab High Yield Process PlaceboBiogenAbbVieCompleted18 Years55 YearsAll1841Phase 3United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Bulgaria;Egypt;Slovenia
830NCT01127750
(ClinicalTrials.gov)
May 201019/5/2010Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) PatientsA 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: FTY720NovartisNULLCompleted18 Years65 YearsAll2417Phase 3Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom
831EUCTR2009-016824-29-DK
(EUCTR)
06/04/201025/02/2010REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIRREsPons 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 CenterNULLNot RecruitingFemale: yes
Male: yes
10Denmark
832NCT01071512
(ClinicalTrials.gov)
April 201017/2/2010Tysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisTysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisMultiple SclerosisDrug: TysabriUniversity of ChicagoBiogenCompleted18 Years60 YearsAll20N/AUnited States
833EUCTR2009-012989-30-BG
(EUCTR)
31/03/201019/04/2010A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
834NCT01051349
(ClinicalTrials.gov)
March 31, 201015/1/2010Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple SclerosisA Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)Relapsing-Remitting Multiple SclerosisBiological: BIIB019 (Daclizumab);Biological: trivalent seasonal influenza vaccineBiogenAbbVieCompleted18 Years60 YearsAll410Phase 2Czechia;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Czech Republic
835EUCTR2009-010788-18-BE
(EUCTR)
16/03/201012/08/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
836NCT01071083
(ClinicalTrials.gov)
March 201017/2/2010Treatment Interruption of NatalizumabRandomized Treatment Interruption of NatalizumabRelapsing Remitting Multiple SclerosisDrug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetateBiogenElan PharmaceuticalsCompleted18 Years60 YearsAll175Phase 2United States;Germany;Spain
837NCT01097668
(ClinicalTrials.gov)
March 201031/3/2010ATX-MS-1467 in Patients With Relapsing Forms of Multiple SclerosisSAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).Relapsing Remitting Multiple SclerosisBiological: ATX-MS-1467Apitope Technology (Bristol) Ltd.Aptiv Solutions;ClinStar, LLCCompleted18 Years55 YearsAll43Phase 1Russian Federation;United Kingdom
838NCT01058005
(ClinicalTrials.gov)
March 201026/1/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BG00002 (natalizumab);Drug: interferon beta-1a;Drug: glatiramer acetateBiogenElan PharmaceuticalsTerminated18 Years60 YearsAll84Phase 3United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden
839EUCTR2009-012989-30-SE
(EUCTR)
23/02/201001/02/2010A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
840NCT01424423
(ClinicalTrials.gov)
February 11, 20109/6/2011NOGO-A in Multiple Sclerosis FTIHA Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying TherapyMultiple SclerosisDrug: Placebo;Drug: GSK1223249GlaxoSmithKlineNULLTerminated18 Years55 YearsAll3Phase 1Australia
841NCT01414634
(ClinicalTrials.gov)
February 20108/8/2011Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear CellsEstablish Tolerance in Multiple Sclerosis With Peptide-coupled, Peripheral Blood Mononuclear Cells - A MRI-controlled, Single Center, Phase I Trial in Relapsing-remitting MS PatientsMultiple Sclerosis, Relapsing-RemittingBiological: ETIMSUniversitätsklinikum Hamburg-EppendorfNULLCompleted18 Years55 YearsAll9Phase 1/Phase 2NULL
842NCT00988988
(ClinicalTrials.gov)
February 201030/9/2009The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate InjectionsThe Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer AcetateMultiple SclerosisDrug: AGEE cream;Drug: 1% Steroid Cream;Drug: topical placebo cream with no active ingredientsUniversity of NebraskaTeva Pharmaceutical IndustriesWithdrawn19 Years65 YearsBoth0Phase 4United States
843EUCTR2008-004954-34-AT
(EUCTR)
21/01/201009/12/2008Long-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Portugal;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
844EUCTR2009-012989-30-FR
(EUCTR)
18/01/201022/09/2009A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - -A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden
845EUCTR2009-010788-18-DE
(EUCTR)
08/01/201011/08/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated inGenzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: N/A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
846EUCTR2009-012989-30-LT
(EUCTR)
30/12/200902/10/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
847NCT00963833
(ClinicalTrials.gov)
December 17, 200921/8/2009Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple SclerosisStudy Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 Years16 YearsAll68N/AAustria;Belgium;Finland;Germany;Israel;United Kingdom;Italy;Portugal
848NCT00986960
(ClinicalTrials.gov)
December 200929/9/2009Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up StudyMultiple SclerosisDrug: repository corticotropin injection;Drug: SalineUniversity at BuffaloNULLTerminated18 Years65 YearsAll3Phase 2United States
849NCT01051817
(ClinicalTrials.gov)
December 200919/1/2010POC-MD MRI-based Trial in Relapsing-remitting Multiple SclerA 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 SclerosisRelapsing-remitting Multiple Sclerosis;RRMSDrug: AIN457;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll73Phase 2Czech Republic;Russian Federation;Ukraine;Serbia;Sweden
850NCT02442557
(ClinicalTrials.gov)
December 20091/5/2015Safety and Dose-finding Study of DC-TAB in Healthy SubjectsA Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and T-cell Tolerizing Effect of DC-TAB in Healthy VolunteersMultiple SclerosisBiological: recombinant human alpha B-crystallin;Other: placebo comparatorDelta Crystallon BVNULLCompleted18 Years55 YearsBoth76Phase 1Netherlands
851NCT00913510
(ClinicalTrials.gov)
December 20093/6/2009Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder DysfunctionEfficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple SclerosisBladder Dysfunction;Multiple SclerosisDevice: CIC using LoFric Primo;Drug: Anticholinergic medicationWellspect HealthCareNULLTerminated18 YearsN/AAll24N/ABelgium;Germany;Netherlands;United Kingdom;France
852NCT01037088
(ClinicalTrials.gov)
December 200917/12/2009Effects of Vaporized Marijuana on Neuropathic PainCCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic PainNeuropathic Pain;Reflex Sympathetic Dystrophy;Peripheral Neuropathy;Post-herpetic Neuralgia;Spinal Cord Injury;Multiple SclerosisDrug: Mild dose cannabis;Drug: Low dose cannabis;Drug: CannabisUniversity of California, DavisCenter for Medicinal Cannabis Research;VA Northern California Health Care SystemCompleted18 Years70 YearsAll44Phase 1/Phase 2United States
853EUCTR2009-010788-18-DK
(EUCTR)
24/11/200905/10/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Alemtuzumab
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
854EUCTR2009-012989-30-GB
(EUCTR)
17/11/200913/07/2009 A clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
542 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Estonia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Georgia;Netherlands;Germany;Sweden
855EUCTR2009-012989-30-CZ
(EUCTR)
16/11/200910/09/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
856NCT00988052
(ClinicalTrials.gov)
November 10, 200928/9/2009A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MSA Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MSRelapsing Multiple SclerosisDrug: LaquinimodTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminated18 Years55 YearsAll839Phase 3United States;Austria;Bulgaria;Canada;Czechia;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;Latvia
857EUCTR2009-010788-18-CZ
(EUCTR)
02/11/200914/09/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: N.A.
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden
858NCT00950248
(ClinicalTrials.gov)
November 1, 200930/7/2009Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)Double Blind Placebo-Controlled Phase I/II Clinical Trial of Idebenone in Patients With Primary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisDrug: Idebenone;Other: placeboNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years65 YearsAll85Phase 1/Phase 2United States
859NCT01049451
(ClinicalTrials.gov)
November 200913/1/2010Pulse ACTH vs. MP for MSComparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif)Multiple SclerosisDrug: ACTH;Drug: MethylprednisoloneUniversity of Southern CaliforniaNULLCompleted18 Years65 YearsAll23Phase 1United States
860NCT01028209
(ClinicalTrials.gov)
November 20098/12/2009Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F] PBR06Institute for Neurodegenerative DisordersNULLTerminated18 YearsN/AAll12Phase 1United States
861NCT01198132
(ClinicalTrials.gov)
November 20098/9/2010A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times WeeklyA Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times WeeklyMultiple SclerosisDietary Supplement: Cholecalciferol (Vitamin D3);Dietary Supplement: Placebo;Drug: RebifMerck KGaAMerck Serono S.A.S, FranceCompleted18 Years65 YearsAll129Phase 2France
862EUCTR2009-011585-28-ES
(EUCTR)
30/10/200924/08/2009A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)Estudio fase IIa, aleatorizado, doble ciego, controlado con placebo, de BGC20-0134 administrado de forma oral en pacientes con esclerosis múltiple recurrente remitente (EMRR)?A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)Estudio fase IIa, aleatorizado, doble ciego, controlado con placebo, de BGC20-0134 administrado de forma oral en pacientes con esclerosis múltiple recurrente remitente (EMRR)? Esclerosis Múltiple Recurrente-RemitenteRelapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: BGC20-0134
Product Code: BGC20-0134
Other descriptive name: Glicerol-1,3-didecanoato-2-octadeca-(6Z,9Z,12Z)-trienoato
BTG International LtdNULLNot RecruitingFemale: yes
Male: yes
166Phase 2Germany;Belgium;France;Spain
863EUCTR2009-012989-30-ES
(EUCTR)
21/10/200905/08/2009Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - -Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - - Esclerosis Múltiple Remitente Recurrente (RRMS).
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsulas 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden
864EUCTR2009-012989-30-IT
(EUCTR)
06/10/200911/09/2009A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - NDA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND Relapsing - Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod
INN or Proposed INN: Laquinimod
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden
865EUCTR2009-012989-30-NL
(EUCTR)
02/10/200920/07/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
632Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden
866NCT01006265
(ClinicalTrials.gov)
October 1, 200930/10/2009Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple SclerosisMulticenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: ACT-128800 Dose 1;Drug: Placebo;Drug: ACT-128800 Dose 2;Drug: ACT-128800 Dose 3ActelionNULLCompleted18 Years55 YearsAll464Phase 2Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Austria;Belgium;United States;Czech Republic
867NCT02275741
(ClinicalTrials.gov)
October 200922/10/2014Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple SclerosisStudy to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal)Dr. med. Micha LoebermannNULLCompleted18 Years70 YearsAll226Germany
868NCT01225289
(ClinicalTrials.gov)
October 20096/9/2010Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis PatientsThe Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple SclerosisRelapsing Remitting Multiple SclerosisDietary Supplement: Vitamin A;Drug: PlaceboTehran University of Medical SciencesNULLCompleted20 Years45 YearsAll36Phase 4Iran, Islamic Republic of
869EUCTR2009-012989-30-EE
(EUCTR)
11/09/200905/08/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden
870EUCTR2008-006333-27-ES
(EUCTR)
11/09/200902/07/2009Estudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis. - ADVANCEEstudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis. - ADVANCE Esclerosis múltiple recidivanteRelapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado
Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado
Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Phase 3Czech Republic;Estonia;Greece;Belgium;Spain;Bulgaria;Netherlands;Germany;Latvia;United Kingdom
871EUCTR2009-012989-30-HU
(EUCTR)
09/09/200914/08/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
632Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden
872EUCTR2008-004954-34-PL
(EUCTR)
09/09/200905/06/2009Long-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: 14.0;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: Rebif
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
873NCT00981084
(ClinicalTrials.gov)
September 200918/9/2009Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover StudyMultiple SclerosisDrug: armodafinilUniversity of Missouri, Kansas CityUniversity of KansasCompleted18 Years60 YearsAll33Phase 2/Phase 3United States
874NCT00930553
(ClinicalTrials.gov)
August 200926/6/2009An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabMultiple Sclerosis, Relapsing-RemittingBiological: alemtuzumabGenzyme, a Sanofi CompanyBayerCompletedN/AN/AAll1314Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Czech Republic
875NCT00970333
(ClinicalTrials.gov)
August 200931/8/2009Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological ConditionsEvaluation of [18F] FEPPA and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F]-FEPPAInstitute for Neurodegenerative DisordersNULLCompleted18 YearsN/ABoth3Phase 1United States
876NCT00871780
(ClinicalTrials.gov)
August 200926/3/2009A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) PatientsA Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER StudyRelapsing Remitting Multiple Sclerosis (RRMS)Drug: BG00002 (natalizumab)BiogenElan PharmaceuticalsCompleted18 Years60 YearsAll224Phase 4Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela
877EUCTR2008-006786-92-ES
(EUCTR)
04/07/200906/05/2009Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitenteEstudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitente Esclerosis Múltiple Recurrente-Remitente
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden
878EUCTR2008-002626-11-SE
(EUCTR)
02/07/200924/04/2009Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosisIntrathecal 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 NeurologyNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
879EUCTR2009-010788-18-GB
(EUCTR)
01/07/200913/07/2009An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MabCampath®
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: N.A.
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
1500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Sweden;Germany;Netherlands;Australia;Denmark;Belgium;Brazil;Poland;Argentina;Canada;Mexico;Czech Republic;United Kingdom;Italy;Russian Federation;Israel;Austria;Ukraine;Spain
880NCT00965497
(ClinicalTrials.gov)
July 20097/8/2009Escitalopram (Lexapro) for Depression MS or ALSAn Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple SclerosisMajor Depression;Multiple Sclerosis;Amyotrophic Lateral SclerosisDrug: escitalopramUniversity of South CarolinaNULLCompleted18 Years70 YearsAll13Phase 3United States
881NCT00947752
(ClinicalTrials.gov)
July 200925/7/2009Safety of New Formulation of Glatiramer AcetateAn Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous InjectionRelapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Experimental Glatiramer AcetateTeva Pharmaceutical IndustriesNULLCompleted18 YearsN/AAll147Phase 3United States
882EUCTR2009-011523-31-GB
(EUCTR)
23/06/200916/04/2009A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VACA study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC The vaccinations are being used to investigate immunological memory following treatment of multiple sclerosis with the lympho-depleting humanised monoclonal antibody alemtuzumab.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10046859;Term: Vaccination
Trade Name: Menitorix
Trade Name: Pneumovax II
Trade Name: REVAXIS
R & D, Cambridge University HospitalsNULLNot RecruitingFemale: yes
Male: yes
60United Kingdom
883NCT00906399
(ClinicalTrials.gov)
June 200920/5/2009Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple SclerosisA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: BIIB017 (peginterferon beta-1a);Drug: PlaceboBiogenNULLCompleted18 Years65 YearsAll1516Phase 3United States;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Estonia;France;Georgia;Germany;Greece;India;Latvia;Mexico;Netherlands;New Zealand;Peru;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
884EUCTR2008-004954-34-BG
(EUCTR)
28/05/200929/05/2009Long-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Portugal;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
885EUCTR2008-004954-34-GR
(EUCTR)
19/05/200906/03/2009Double-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) - REFLEXIONDouble-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, DarmstadtNULLNot RecruitingFemale: yes
Male: yes
492Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
886EUCTR2008-004954-34-DE
(EUCTR)
05/05/200915/01/2009Long-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
887NCT00799890
(ClinicalTrials.gov)
May 200928/11/2008Sunphenon in Progressive Forms of Multiple SclerosisMonocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple SclerosisMultiple SclerosisDrug: Sunphenon EGCG;Drug: PlaceboFriedemann PaulTAIYO EUROPECompleted18 Years65 YearsAll61Phase 2/Phase 3Germany
888EUCTR2008-008719-25-ES
(EUCTR)
21/04/200906/03/2009Estudio fase II, a doble ciego, aleatorizado y multicéntrico, con esquema adaptativo de dosis, controlado con placebo y de grupos paralelos, para evaluar la eficacia, tolerabilidad y seguridad en base a parámetros de lesión observados mediante resonancia magnética, así como determinar la curva dosis - respuesta de BAF312 administrado oralmente en dosis única diaria en pacientes con Esclerosis Múltiple remitente recurrente.Estudio fase II, a doble ciego, aleatorizado y multicéntrico, con esquema adaptativo de dosis, controlado con placebo y de grupos paralelos, para evaluar la eficacia, tolerabilidad y seguridad en base a parámetros de lesión observados mediante resonancia magnética, así como determinar la curva dosis - respuesta de BAF312 administrado oralmente en dosis única diaria en pacientes con Esclerosis Múltiple remitente recurrente. Esclerosis Múltiple remitente recurrente
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Code: BAF312
Product Code: BAF312
Product Code: BAF312
Product Code: BAF312
Novartis Farmacéutica, S.ANULLNot RecruitingFemale: yes
Male: yes
275Hungary;Finland;Germany;Spain;Italy
889EUCTR2008-004954-34-FR
(EUCTR)
08/04/200917/03/2009Double-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) - REFLEXIONDouble-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
890EUCTR2008-004954-34-IT
(EUCTR)
08/04/200912/03/2009Double-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) - REFLEXIONDouble-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 SANULLNot RecruitingFemale: yes
Male: yes
492Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
891NCT00914290
(ClinicalTrials.gov)
April 20092/6/2009A Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisA Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisSpasticity;Multiple SclerosisDrug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IRImpax Laboratories, LLCNULLCompleted18 YearsN/AAll23Phase 2United States
892NCT00881205
(ClinicalTrials.gov)
April 200914/4/2009Rivastigmine in Multiple Sclerosis Patients With Cognitive ImpairmentA 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment PhaseMultiple Sclerosis;Cognitive ImpairmentDrug: Rivastigmine transdermal patch;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll86Phase 4Germany
893NCT00882999
(ClinicalTrials.gov)
April 200916/4/2009A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years64 YearsAll245Phase 2United States;Bulgaria;Czechia;France;Germany;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;Belgium;Canada;Czech Republic;Denmark;Finland;Switzerland
894NCT00904826
(ClinicalTrials.gov)
April 200918/5/2009An Open Label Study of the Effects of Eculizumab in Neuromyelitis OpticaAn Open Label Study of the Effects of Eculizumab in Neuromyelitis OpticaNeuromyelitis Optica;Devic's DiseaseDrug: EculizumabMayo ClinicAlexion PharmaceuticalsCompleted18 YearsN/AAll14Phase 1/Phase 2United States
895NCT00883337
(ClinicalTrials.gov)
April 200916/4/2009A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension PeriodMultiple SclerosisDrug: Interferon ß-1a;Drug: TeriflunomideSanofiNULLCompleted18 YearsN/AAll324Phase 3Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom
896NCT00879658
(ClinicalTrials.gov)
March 30, 20099/4/2009Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple SclerosisA Phase II, Double-blind, Randomized, Multi-center, Adaptive Dose-ranging, Placebo-controlled, Parallel-group Study Evaluating Safety, Tolerability and Efficacy on MRI Lesion Parameters and Determining the Dose Response Curve of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis.Relapsing-remitting Multiple SclerosisDrug: BAF312;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll297Phase 2United States;Canada;Finland;Germany;Hungary;Italy;Norway;Poland;Russian Federation;Spain;Switzerland;Turkey
897EUCTR2008-006226-34-ES
(EUCTR)
25/03/200923/01/2009Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENEREEstudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE Esclerosis Múltiple------------------------Multiple sclerosisProduct Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: REBIF 44 microgramos solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
sanofi-aventis recherche et developmentNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy
898NCT00884481
(ClinicalTrials.gov)
March 23, 200917/4/2009Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMSA Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 MonthsRelapsing-Remitting Multiple Sclerosis;FatigueOther: NatalizumabBiogenNULLCompleted18 Years65 YearsAll195Austria;Denmark;Norway;Sweden;United States
899EUCTR2008-004954-34-LV
(EUCTR)
12/03/200927/02/2009Double-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) - REFLEXIONDouble-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Germany
900EUCTR2008-004954-34-BE
(EUCTR)
09/03/200923/01/2009Long-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
901EUCTR2008-004954-34-SK
(EUCTR)
05/03/200909/09/2009Long-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: 13.1;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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
902EUCTR2008-004954-34-ES
(EUCTR)
03/03/200919/12/2008Extensión 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) - REFLEXIONExtensión 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, DarmstadtNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
903NCT00853762
(ClinicalTrials.gov)
March 200926/2/2009Atacicept in Multiple Sclerosis Extension Study, Phase IIAn Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)Relapsing Multiple SclerosisDrug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mgEMD SeronoMerck KGaATerminated18 Years60 YearsAll74Phase 2United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
904NCT00837785
(ClinicalTrials.gov)
February 28, 20094/2/2009A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MSA 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BG00012BiogenNULLCompleted18 Years55 YearsAll48Phase 1Germany;United Kingdom
905EUCTR2008-004954-34-EE
(EUCTR)
13/02/200908/01/2009Long-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Portugal;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
906EUCTR2008-004954-34-PT
(EUCTR)
06/02/200905/01/2009Double-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) - REFLEXIONDouble-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
907NCT00835770
(ClinicalTrials.gov)
February 3, 20092/2/2009BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: dimethyl fumarate;Drug: PlaceboBiogenNULLCompleted19 Years58 YearsAll1736Phase 3United States;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Greece;India;Ireland;Israel;Italy;Latvia;Mexico;Moldova, Republic of;Netherlands;New Zealand;North Macedonia;Poland;Puerto Rico;Romania;Serbia;Slovakia;South Africa;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Guatemala;Macedonia, The Former Yugoslav Republic of
908NCT03408093
(ClinicalTrials.gov)
February 3, 20098/1/2018Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1bCross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1bMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years100 YearsAll120NULL
909NCT00870740
(ClinicalTrials.gov)
February 200926/3/2009Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple SclerosisA Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)Relapsing-Remitting Multiple SclerosisBiological: BIIB019 (Daclizumab High Yield Process);Drug: PlaceboBiogenAbbVieCompleted18 Years55 YearsAll517Phase 2Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom
910NCT00836719
(ClinicalTrials.gov)
February 20093/2/2009Safety of Polyphenon E in Multiple Sclerosis Pilot StudySafety and Neuroprotective Effects of Polyphenon E in Multiple SclerosisMultiple SclerosisDrug: Polyphenon ELouisiana State University Health Sciences Center in New OrleansNational Center for Complementary and Integrative Health (NCCIH)Completed18 Years65 YearsAll10Phase 1United States
911EUCTR2008-001999-67-ES
(EUCTR)
30/01/200917/11/2008Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple SclerosisEstudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis Esclerosis Múltiple______________Multiple Sclerosis
MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term:
Product Name: Nerispirdine hydrochloride
Product Code: HP184
INN or Proposed INN: Nerispirdine hydrochloride
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
368Phase 2France;Finland;Spain;Germany
912EUCTR2008-003706-33-ES
(EUCTR)
29/01/200909/12/2008A 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) TrialA 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
913EUCTR2008-004954-34-FI
(EUCTR)
26/01/200917/12/2008Long-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: 13.1;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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
914NCT00876447
(ClinicalTrials.gov)
January 1, 20091/4/2009A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple SclerosisOveractive BladderBiological: Botulinum Toxin Type A 300U;Biological: Botulinum Toxin Type A 200UAllerganNULLCompleted18 YearsN/AAll397Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Singapore;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic
915NCT00828204
(ClinicalTrials.gov)
January 200920/1/2009Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis SubjectsAn Open-Label, Multicenter Study to Evaluate the Safe and Effective Use of the Single-Use Autoinjector With an Avonex® Prefilled Syringe in Multiple Sclerosis SubjectsMultiple SclerosisDevice: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a)BiogenNULLCompleted18 Years65 YearsAll95Phase 3United States
916NCT00666887
(ClinicalTrials.gov)
January 200923/4/2008Minocycline in Clinically Isolated Syndromes (CIS)A Phase III Double-blind, Randomized, Placebo-controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS)Clinically Isolated Syndromes;Early Single Relapse of Multiple SclerosisDrug: Minocycline;Drug: PlaceboDr. Luanne MetzMultiple Sclerosis Society of CanadaCompleted18 Years60 YearsAll142Phase 3Canada
917NCT00841321
(ClinicalTrials.gov)
January 20099/2/2009Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple SclerosisGinkgo Biloba for Cognitive Impairment in Multiple SclerosisMultiple Sclerosis;Cognitive Ability, GeneralDrug: Ginkgo biloba;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years65 YearsAll120Phase 2United States
918NCT00725985
(ClinicalTrials.gov)
December 31, 200830/7/2008Oral Cladribine in Early Multiple Sclerosis (MS)A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MSMultiple SclerosisDrug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF)EMD SeronoNULLCompleted18 Years55 YearsAll617Phase 3United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Saudi Arabia
919EUCTR2008-004954-34-CZ
(EUCTR)
12/12/200821/11/2008Long-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, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
920NCT00813709
(ClinicalTrials.gov)
December 200822/12/2008Long-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)Multiple Sclerosis;Clinically Isolated SyndromeDrug: RNF;Drug: PlaceboMerck KGaANULLCompleted18 YearsN/AAll402Phase 3Argentina;Austria;Belgium;Bulgaria;Canada;Croatia;Czech Republic;Estonia;Finland;France;Germany;Greece;Israel;Italy;Latvia;Lebanon;Morocco;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Saudi Arabia;Turkey
921EUCTR2007-001162-32-AT
(EUCTR)
23/10/200814/07/2008A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
573Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
922EUCTR2007-001161-14-PL
(EUCTR)
21/10/200812/05/2008?Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I 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: MabCampath ®
Product Name: MabCampath®
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
Product Name: Rebif®
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
923EUCTR2007-001162-32-PL
(EUCTR)
21/10/200824/10/2008Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II 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: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
840Phase 3Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
924NCT00755807
(ClinicalTrials.gov)
October 200817/9/2008Duloxetine for Multiple Sclerosis PainDuloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.Multiple SclerosisDrug: Duloxetine Hydrochloride (HCI);Drug: PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll239Phase 3United States;Belgium;Canada;Poland
925NCT00784836
(ClinicalTrials.gov)
October 200829/10/2008Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) PatientsA Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: BG9418 (interferon beta 1-a)BiogenNULLTerminated18 Years60 YearsAll3Phase 3United States
926NCT00780455
(ClinicalTrials.gov)
October 200828/5/2008Rehabilitation Study in MS PatientsMulticenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®Multiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1b, FRP within 15 days after randomization;Drug: Interferon beta-1b, FRP about 6 weeks after randomizationBayerNULLTerminated18 YearsN/AAll4Phase 4France
927EUCTR2006-006299-39-FR
(EUCTR)
24/09/200806/08/2007A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory ImpairmentA Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment.
MedDRA version: 8.1;Level: LLT;Classification code 10046543;Term: Urinary incontinence
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: 9060X
INN or Proposed INN: Botulinum toxin type A
Other descriptive name: Botulinum toxin type A
AllerganNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Netherlands;France
928EUCTR2007-001162-32-DK
(EUCTR)
20/08/200825/07/2008Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
840Phase 3Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Belgium;Denmark;Argentina;Mexico;Spain;Croatia;United States;Poland
929EUCTR2007-001162-32-IT
(EUCTR)
06/08/200814/07/2008A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-IIA Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II 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]
Trade Name: MABCAMPATH
INN or Proposed INN: Alemtuzumab
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
573Phase 3France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
930NCT00751881
(ClinicalTrials.gov)
August 20087/5/2008An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple SclerosisA Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: TeriflunomideSanofiNULLCompleted18 Years55 YearsAll1169Phase 3United States;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Czech Republic;Estonia;France;Germany;Greece;Mexico;Netherlands;Philippines;Poland;Romania;Slovakia;Spain;Sweden;Thailand;Tunisia;Turkey;Ukraine;United Kingdom;South Africa
931NCT00676715
(ClinicalTrials.gov)
July 31, 20089/5/2008A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple SclerosisPhase 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 RRMSMultiple Sclerosis, Relapsing-RemittingDrug: Placebo;Drug: Ocrelizumab;Drug: AvonexGenentech, Inc.Roche Pharma AGActive, not recruiting18 Years55 YearsAll220Phase 2United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Italy;Mexico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands
932EUCTR2007-001162-32-CZ
(EUCTR)
30/07/200831/03/2008A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
573Phase 3France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
933NCT00731692
(ClinicalTrials.gov)
July 28, 20087/8/2008This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisDrug: FTY720;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated25 Years65 YearsAll970Phase 3United States;Australia;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic
934EUCTR2007-001162-32-SE
(EUCTR)
28/07/200828/12/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
840Phase 3Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
935EUCTR2007-002627-32-ES
(EUCTR)
17/07/200808/05/2008Estudio 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 progresivaEstudio 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.ANULLNot RecruitingFemale: yes
Male: yes
650France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
936EUCTR2007-006338-32-ES
(EUCTR)
16/07/200828/03/2008Estudio 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 sclerosisEstudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom
937NCT00735007
(ClinicalTrials.gov)
July 200812/8/200812-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.International, Multicenter, Single-arm, Open-label, 12-week Phase IIIb Study to Evaluate RebiSmart™ Suitability for Self Injection of Rebif® New Formulation (RNF) in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis (RMS)Multiple SclerosisDrug: Rebif® New Formulation (RNF) using RebiSmartTMEMD SeronoNULLCompleted18 Years65 YearsAll106Phase 3United States;Canada;Germany;Italy;Spain;Sweden
938NCT00645749
(ClinicalTrials.gov)
July 200825/3/2008Helminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple SclerosisHelminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisBiological: Helminth ovaUniversity of Wisconsin, MadisonNational Multiple Sclerosis SocietyCompleted18 Years50 YearsAll17Phase 1United States
939EUCTR2007-001162-32-DE
(EUCTR)
02/06/200802/01/2008Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II 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: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
840Phase 3Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
940NCT03577977
(ClinicalTrials.gov)
June 1, 200825/6/2018Betaferon Use in Children and Adolescents With Multiple SclerosisRetrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)BayerNULLCompletedN/A18 YearsAll70Russian Federation
941NCT00716066
(ClinicalTrials.gov)
June 200815/7/2008Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune DiseasesHigh-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic DiseasesAutoimmune 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 EncephalitisBiological: 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 TransplantationFred Hutchinson Cancer Research CenterNULLRecruitingN/A71 YearsAll40Phase 2United States
942EUCTR2007-001162-32-BE
(EUCTR)
26/05/200822/01/2008A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
573Phase 3France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
943EUCTR2007-003226-19-BG
(EUCTR)
22/05/200822/03/2008Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1419Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
944EUCTR2007-001161-14-SE
(EUCTR)
21/05/200818/12/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple SclerosisA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I 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: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Germany;France;Sweden;Australia;Brazil;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
945EUCTR2007-000888-15-ES
(EUCTR)
19/05/200827/02/2008ENSAYO 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 MúltipleENSAYO 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 NeurologíaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
946EUCTR2007-001162-32-NL
(EUCTR)
06/05/200819/12/2007A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
947NCT00640328
(ClinicalTrials.gov)
May 200818/3/2008Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) PatientsA Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) PatientsMultiple SclerosisDrug: Ofatumumab 100;Drug: Ofatumumab 300;Drug: Ofatumumab 700;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years55 YearsAll38Phase 2Belgium;Czech Republic;Denmark;Former Serbia and Montenegro;Germany;Poland;Serbia;Sweden;United Kingdom
948NCT00605215
(ClinicalTrials.gov)
April 24, 20088/1/2008BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®)A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded DesignMultiple SclerosisDrug: Laquinimod;Drug: Placebo;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years55 YearsAll1331Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Latvia;Macedonia, The Former Yugoslav Republic of;Montenegro;Turkey
949EUCTR2006-006299-39-NL
(EUCTR)
23/04/200813/06/2007A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory ImpairmentA Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment.
MedDRA version: 8.1;Level: LLT;Classification code 10046543;Term: Urinary incontinence
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: 9060X
INN or Proposed INN: Botulinum toxin type A
Other descriptive name: Botulinum toxin type A
AllerganNULLNot RecruitingFemale: yes
Male: yes
135Netherlands;France
950EUCTR2007-001162-32-FR
(EUCTR)
11/04/200808/01/2008A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
951EUCTR2007-001161-14-FR
(EUCTR)
11/04/200808/01/2008A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-IA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3France;Czech Republic;Poland;Germany;United Kingdom;Sweden
952EUCTR2007-001161-14-CZ
(EUCTR)
09/04/200811/09/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple SclerosisA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Sclerosis. - CARE MS-I 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: MabCampath®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif®
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Germany;France;Australia;Brazil;Sweden;Czech Republic;Russian Federation;United Kingdom;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
953NCT00670449
(ClinicalTrials.gov)
April 200828/4/2008An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple SclerosisAn Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: FingolimodNovartisMitsubishi Tanabe Pharma CorporationCompleted18 Years60 YearsAll143Phase 2Japan
954NCT00642902
(ClinicalTrials.gov)
April 200821/3/2008A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment CourseRelapsing Multiple SclerosisDrug: Atacicept;Drug: Placebo matched to ataciceptEMD SeronoNULLTerminated18 Years60 YearsAll255Phase 2United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
955NCT00629642
(ClinicalTrials.gov)
March 14, 200826/2/2008Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple SclerosisA Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor OveractivityMultiple Sclerosis;Neurogenic Bladder;Spinal Cord DiseasesDrug: Solifenacin Succinate;Drug: Oxybutynin Hydrochloride;Drug: PlaceboAstellas Pharma IncNULLCompleted18 Years65 YearsAll249Phase 4Australia;Belgium;Czechia;France;Germany;Hungary;Italy;Netherlands;Russian Federation;Spain;United Kingdom;Czech Republic;Portugal
956EUCTR2007-000192-42-IT
(EUCTR)
10/03/200831/07/2007A 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 - NDA 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
ALLERGANNULLNot RecruitingFemale: yes
Male: yes
260Portugal;United Kingdom;Germany;Netherlands;France;Spain;Italy
957EUCTR2007-003936-50-ES
(EUCTR)
10/03/200802/01/2008Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMSEstudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS Esclerosis múltiple recidivante Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: atacicept
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
332Phase 2France;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;United Kingdom;Sweden
958NCT00641537
(ClinicalTrials.gov)
February 29, 200813/3/2008CLARITY Extension StudyA 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 SclerosisDrug: Cladribine;Drug: PlaceboEMD Serono Research & Development Institute, Inc.NULLCompleted18 Years65 YearsAll867Phase 3United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Italy;Latvia;Lebanon;Lithuania;Morocco;Netherlands;Poland;Portugal;Russian Federation;Saudi Arabia;Serbia;Switzerland;Tunisia;Turkey;Ukraine;United Kingdom;Czech Republic;Former Serbia and Montenegro
959EUCTR2007-001162-32-ES
(EUCTR)
22/02/200814/02/2008Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-IIEstudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II Esclerosis Múltiple de recaída-remisión
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
960EUCTR2007-001161-14-DE
(EUCTR)
06/02/200823/08/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple SclerosisA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I 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: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
961EUCTR2005-002305-23-GB
(EUCTR)
05/02/200814/01/2008A pilot study of combination monoclonal antibody treatment in early active relapsing-remitting multiple sclerosis using Campath-1H and its non-binding form, SM3. - SM3A pilot study of combination monoclonal antibody treatment in early active relapsing-remitting multiple sclerosis using Campath-1H and its non-binding form, SM3. - SM3 Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
R&D Addenbrookes HospitalNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
962EUCTR2007-003226-19-PT
(EUCTR)
01/02/200824/10/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
963NCT00662649
(ClinicalTrials.gov)
February 200817/4/2008Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple SclerosisAn Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Fingolimod 0.5 mg;Drug: Fingolimod 1.25 mgNovartisNULLCompleted20 Years58 YearsAll920Phase 3Australia;Belgium;Canada;Czech Republic;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Poland;Romania;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom;Israel;Netherlands
964NCT00390221
(ClinicalTrials.gov)
February 200817/10/2006Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple SclerosisMulticenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisBiological: BIIB019 (Daclizumab High Yield Process);Drug: PlaceboBiogenAbbVieCompleted18 Years55 YearsAll621Phase 2Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Australia;Former Serbia and Montenegro;Sweden;Turkey
965NCT00622700
(ClinicalTrials.gov)
February 200814/2/2008Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple SclerosisAn International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension PeriodMultiple SclerosisDrug: Teriflunomide;Drug: PlaceboSanofiNULLCompleted18 Years55 YearsAll618Phase 3United States;Australia;Austria;Bulgaria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Turkey;Ukraine;United Kingdom;Brazil;Italy;Slovakia
966EUCTR2007-003226-19-LT
(EUCTR)
11/01/200825/09/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
967NCT00681538
(ClinicalTrials.gov)
January 200819/5/2008A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)A Two-phase, Phase 3 Study of the Safety and Efficacy of Sativex, in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis: Phase A - Single-blind Response Assessment; Phase B - Double-blind, Randomised, Placebo Controlled, Parallel Group Study.Spasticity;Multiple SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll572Phase 3United Kingdom
968NCT00647348
(ClinicalTrials.gov)
January 200826/3/2008Investigation of Simvastatin in Secondary Progressive Multiple SclerosisA Phase II Randomised, Placebo-controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis.Secondary Progressive Multiple SclerosisDrug: Simvastatin;Drug: PlaceboImperial College LondonNULLCompleted18 Years65 YearsAll140Phase 2United Kingdom
969NCT00612872
(ClinicalTrials.gov)
January 200816/1/2008Evaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With PD or AD and in Healthy SubjectsEvaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With Parkinson Disease or Alzheimer Disease and in Healthy SubjectsParkinson Disease;Alzheimer Disease;Healthy Controls;Multiple SclerosisDrug: [123I]CLINDEInstitute for Neurodegenerative DisordersNULLTerminated30 Years50 YearsAll46Phase 1United States
970NCT00536120
(ClinicalTrials.gov)
January 200825/9/2007The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple SclerosisA Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: BG00002 (natalizumab);Biological: keyhole limpet hemocyanin (KLH);Biological: tetanus diphtheria toxoid vaccine (Td)BiogenNULLCompleted18 Years60 YearsAll60Phase 4United States
971NCT00938366
(ClinicalTrials.gov)
January 20089/7/2009Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis SubjectsAn Open-label, Cross Over Study, to Assess the Interactions of Pantoprazole (Proton Pump Inhibitor) With Oral Cladribine Administered in Subjects With Multiple SclerosisMultiple SclerosisDrug: Cladribine;Drug: PantoprazoleMerck KGaAMerck Serono S.A., GenevaCompleted18 Years65 YearsAll18Phase 1NULL
972EUCTR2007-003226-19-SE
(EUCTR)
27/12/200729/10/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Sweden;Lithuania;United Kingdom;Czech Republic;Estonia;Spain
973EUCTR2007-001162-32-GB
(EUCTR)
24/12/200704/10/2007A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
573 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
974EUCTR2007-001958-99-FI
(EUCTR)
18/12/200707/12/2007Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MSCollecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS Patients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Dekristol 20000 IE
Product Name: Dekristol
INN or Proposed INN: INN COLECALCIFEROL
Product Name: Placebo Dekristol SGC 20000
Merja Soilu HäninenNULLNot RecruitingFemale: yes
Male: yes
Finland
975EUCTR2007-003226-19-IT
(EUCTR)
06/12/200710/03/2008A 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). - AllegroA multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - Allegro Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: laquinimod
Product Code: TV-5600
INN or Proposed INN: laquinimod
TEVA ITALIA srlNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
976EUCTR2007-003226-19-EE
(EUCTR)
04/12/200710/10/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
977NCT00623415
(ClinicalTrials.gov)
December 200715/2/2008Flupirtine as Oral Treatment in Multiple SclerosisMulticentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-ß1b on Neurodegeneration in Patients With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Flupirtine;Drug: PlaceboCharite University, Berlin, GermanyBayerTerminated18 Years60 YearsAll30Phase 2Germany
978NCT00573443
(ClinicalTrials.gov)
December 200713/12/2007Safety and Efficacy of AVP-923 in PBA Patients With ALS or MSA Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)Pseudobulbar Affect (PBA)Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: PlaceboAvanir PharmaceuticalsINC ResearchCompleted18 Years80 YearsAll326Phase 3United States;Argentina;Brazil
979EUCTR2007-003997-24-ES
(EUCTR)
26/11/200715/10/2007Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrenciasLong-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias Multiple Sclerosis.-----------------------Esclerosis Múltiple.Product Name: Teriflunomide
Product Code: HMR 1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
Sanofi-Aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
980EUCTR2007-003226-19-ES
(EUCTR)
22/11/200704/10/2007Estudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - AllegroEstudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - Allegro Esclerosis Múltiple Remitente Recurrente (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden
981EUCTR2007-003226-19-LV
(EUCTR)
06/11/200712/09/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
982NCT00702468
(ClinicalTrials.gov)
November 200719/6/2008Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple SclerosisA Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-term Sativex®.Spasticity;Multiple SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll36Phase 3United Kingdom
983NCT00688948
(ClinicalTrials.gov)
November 200730/5/2008Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple SclerosisMultiple Sclerosis;Bladder DysfunctionDrug: AlfuzosinCapital District Health Authority, CanadaSanofiTerminated18 YearsN/ABoth20Phase 2/Phase 3Canada
984NCT00595920
(ClinicalTrials.gov)
November 20073/1/2008Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple SclerosisAn Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated SyndromeBiological: TovaxinOpexa Therapeutics, Inc.NULLTerminatedN/AN/AAll116Phase 2United States
985EUCTR2007-003226-19-CZ
(EUCTR)
25/10/200710/09/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;Czech Republic;United Kingdom;Estonia;Spain
986EUCTR2007-003226-19-GB
(EUCTR)
24/10/200701/08/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
987EUCTR2007-003226-19-DE
(EUCTR)
23/10/200715/07/2008Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden
988EUCTR2007-003226-19-HU
(EUCTR)
09/10/200713/07/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
989NCT00811395
(ClinicalTrials.gov)
October 200718/12/2008Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple SclerosisLong-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA]SanofiNULLCompleted18 Years55 YearsAll182Phase 2United States;Austria;Canada;Germany;Italy;Spain;United Kingdom
990NCT00548405
(ClinicalTrials.gov)
October 200722/10/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study TwoA Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On TherapyMultiple Sclerosis, Relapsing-RemittingBiological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg;Biological: Interferon beta-1aGenzyme, a Sanofi CompanyBayerCompleted18 Years55 YearsAll840Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czech Republic;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom
991EUCTR2007-003226-19-AT
(EUCTR)
30/09/200719/09/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
992EUCTR2007-003226-19-FR
(EUCTR)
21/09/200706/08/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden
993NCT02523703
(ClinicalTrials.gov)
September 10, 200713/8/2015Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot StudyMultiple SclerosisBiological: glutamate and aspartateUniversity Hospital, CaenNULLCompleted18 Years60 YearsAll36N/ANULL
994EUCTR2007-003226-19-NL
(EUCTR)
05/09/200712/07/2007Study 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) - AllegroStudy 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1419Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
995NCT00525668
(ClinicalTrials.gov)
September 20074/9/2007Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)Relapsing-remitting Multiple SclerosisDrug: epigallocatechin-gallate (Sunphenon);Drug: placeboCharite University, Berlin, GermanyNULLCompleted18 Years60 YearsAll120Phase 1/Phase 2Germany
996NCT00937157
(ClinicalTrials.gov)
September 20079/7/2009Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI StudyMultiple SclerosisDrug: CopaxoneUniversity at BuffaloTeva Neuroscience, Inc.Completed18 Years65 YearsAll12N/AUnited States
997NCT00537082
(ClinicalTrials.gov)
September 200726/9/2007Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: FTY720;Drug: PlaceboNovartisMitsubishi Tanabe Pharma CorporationCompleted18 Years60 YearsAll171Phase 2Japan
998EUCTR2006-003697-10-ES
(EUCTR)
29/08/200728/02/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: glatiramer acetate
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Phase 3Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Latvia
999EUCTR2007-001161-14-GB
(EUCTR)
24/08/200701/08/2007A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-IA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Czech Republic;Germany;United Kingdom;France;Poland;Sweden
1000NCT00530348
(ClinicalTrials.gov)
August 200713/9/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study OneA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: Alemtuzumab;Biological: Interferon beta-1aGenzyme, a Sanofi CompanyBayerCompleted18 Years50 YearsAll581Phase 3United States;Argentina;Australia;Brazil;Canada;Croatia;Czech Republic;France;Germany;Mexico;Poland;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom;Former Serbia and Montenegro
1001NCT00649792
(ClinicalTrials.gov)
August 200728/3/2008Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 TrialPhase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 TrialMultiple SclerosisDrug: Fampridine-SRAcorda TherapeuticsNULLCompleted18 Years70 YearsAll214Phase 3United States;Canada
1002EUCTR2005-004061-41-AT
(EUCTR)
06/07/200715/12/2005An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATAAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
900Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden
1003NCT00469378
(ClinicalTrials.gov)
July 20072/5/2007Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple SclerosisAn Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With FirategrastMultiple SclerosisDrug: firategrastGlaxoSmithKlineNULLCompleted18 Years65 YearsAll46Phase 2Belgium;Czech Republic;Denmark;Norway;Sweden
1004NCT00619307
(ClinicalTrials.gov)
July 20078/2/2008Transition to Rebif New FormulationA Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as ProphylaxisRelapsing Multiple SclerosisDrug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRNMerck KGaANULLCompleted18 Years60 YearsAll117Phase 3France;Germany
1005NCT00467584
(ClinicalTrials.gov)
July 200726/4/2007Aspirin for Treatment of Multiple Sclerosis-Related FatigueAspirin for Treatment of Multiple Sclerosis-Related FatigueMultiple Sclerosis;FatigueDrug: High Dose Aspirin (1300 mg/day);Drug: Low Dose Aspirin (162 mg/day);Drug: PlaceboMayo ClinicNational Multiple Sclerosis SocietyTerminated18 Years65 YearsAll62Phase 3United States
1006NCT00497952
(ClinicalTrials.gov)
July 20076/7/2007Allogeneic Stem Cell Transplantation for the Treatment of Multiple SclerosisAllogeneic Stem Cell Transplantation for the Treatment of Multiple SclerosisMultiple SclerosisBiological: hematopoetic stem cell infusionTalaris Therapeutics Inc.NULLActive, not recruiting18 Years55 YearsAll3Phase 1/Phase 2United States
1007NCT00493298
(ClinicalTrials.gov)
June 29, 200727/6/2007Tysabri Observational ProgramTOP: Tysabri® Observational ProgramRelapsing-Remitting Multiple SclerosisDrug: natalizumabBiogenNULLActive, not recruiting18 Years65 YearsAll6620Argentina;Australia;Belgium;Brazil;Canada;Czechia;Finland;France;Germany;Greece;Italy;Mexico;Netherlands;Norway;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Denmark;Switzerland
1008EUCTR2005-004061-41-SE
(EUCTR)
29/06/200715/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
521Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
1009NCT00451451
(ClinicalTrials.gov)
June 200721/3/2007Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple SclerosisA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: BG00012;Drug: Placebo;Drug: Glatiramer AcetateBiogenNULLCompleted18 Years55 YearsAll1417Phase 3United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Costa Rica;Croatia;Czech Republic;Estonia;France;Germany;Greece;India;Ireland;Israel;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;New Zealand;Poland;Puerto Rico;Romania;Serbia;Slovakia;Spain;Ukraine;Australia;Italy;Kazakhstan;Lithuania;Russian Federation
1010NCT00488839
(ClinicalTrials.gov)
June 200718/6/2007IPX056 in Subjects With Established Spasticity Resulting From Multiple SclerosisA Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple SclerosisMultiple SclerosisDrug: IPX056 20 mg;Drug: IPX056 40 mg;Drug: Encapsulated Baclofen 20 mg;Drug: Placebo Baclofen Tablet;Drug: IPX056 10 mg;Drug: IPX056 30 mg;Drug: IPX056 35 mg;Drug: Placebo IPX056 20 mg;Drug: Placebo IPX056 40 mgImpax Laboratories, LLCNULLCompleted18 YearsN/AAll173Phase 3United States;Canada;Estonia;Latvia;Ukraine
1011EUCTR2006-002204-33-ES
(EUCTR)
04/05/200705/03/2007Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas.Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas. Relapsing forms of multiple slerosisEsclerosis multiple (EM) con recaidas
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: CDP323
Product Code: CDP323
UCB PharmaNULLNot RecruitingFemale: yes
Male: yes
279Phase 2France;Hungary;Finland;Belgium;Spain;Netherlands;Germany;United Kingdom;Sweden
1012NCT00483652
(ClinicalTrials.gov)
May 20076/6/2007Study of Fampridine-SR Tablets in Multiple Sclerosis PatientsDouble-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple SclerosisMultiple SclerosisDrug: Fampridine-SR;Drug: PlaceboAcorda TherapeuticsNULLCompleted18 Years70 YearsAll240Phase 3United States;Canada
1013NCT00459667
(ClinicalTrials.gov)
May 200711/4/2007BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New DoseInternational, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µgMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years55 YearsAll1420Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine
1014NCT00489489
(ClinicalTrials.gov)
May 200720/6/2007Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple SclerosisA Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-beta in Subjects With Multiple Sclerosis.Multiple SclerosisDrug: Teriflunomide;Drug: Placebo (for Teriflunomide);Drug: Interferon-ßSanofiNULLCompleted18 Years55 YearsAll118Phase 2United States;Canada;Germany;Italy;Spain;Poland
1015NCT00548769
(ClinicalTrials.gov)
April 21, 200723/10/2007Firategrast (SB683699) Surface Area Study in Multiple Sclerosis PatientsAn Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple SclerosisMultiple SclerosisDrug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation DGlaxoSmithKlineNULLCompleted18 Years65 YearsAll37Phase 1Czechia;Germany;Poland;Czech Republic
1016EUCTR2006-005270-47-ES
(EUCTR)
08/04/200705/02/2007 Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up Esclerosis Múltiple RecidivanteTrade Name: Betaferon 250 microgramos
INN or Proposed INN: Interferon beta 1b
Product Name: Betaferon 500 µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta 1b
Schering AGNULLNot Recruiting Female: yes
Male: yes
1880 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSlovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
1017NCT00475865
(ClinicalTrials.gov)
April 200718/5/2007Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple SclerosisA Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple SclerosisMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA)SanofiNULLCompleted18 Years55 YearsAll123Phase 2United States;Austria;Canada;Germany;Italy;United Kingdom
1018NCT00472797
(ClinicalTrials.gov)
April 200710/5/2007Rebif New Formulation (RNF) Quality of Life (QOL) StudyA Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)Relapsing Multiple SclerosisDrug: Rebif New Formulation Non Titrated;Drug: Rebif New Formulation TitratedEMD SeronoNULLCompleted18 Years60 YearsAll232Phase 3United States
1019EUCTR2006-003134-14-ES
(EUCTR)
23/02/200726/10/2009A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”.A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. Multiple sclerosis.Esclerosis Múltiple.Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Sanofi-aventis U.S. Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Spain;Germany;Italy
1020EUCTR2006-003366-33-ES
(EUCTR)
13/02/200703/03/2010Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple ActivaEstudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa Pacientes con esclerosis múltiple activa
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
Trade Name: not applicable
Product Name: cladribina oral
Product Code: not applicable
INN or Proposed INN: cladribine
Serono International, S.A.NULLNot RecruitingFemale: yes
Male: yes
290Phase 2Spain;Italy
1021EUCTR2006-003037-32-ES
(EUCTR)
09/02/200710/03/2010Estudio 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 SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Estonia;Spain;Lithuania;Germany;Italy
1022NCT03135327
(ClinicalTrials.gov)
January 1, 200724/4/2017Clinical Applications of Advanced Ophthalmic ImagingClinical Applications of Advanced Ophthalmic ImagingMultiple Sclerosis;Dry Eye Syndromes;Diabetic Retinopathy;Presbyopia;Myopia;DementiaDietary Supplement: OcufolinUniversity of MiamiNULLRecruiting18 Years99 YearsAll5000N/AUnited States
1023NCT00457730
(ClinicalTrials.gov)
January 20074/4/2007A Study to Test the Use of Duloxetine for Pain in MSA Randomized Placebo Controlled Trial of Duloxetine for Central Pain in Multiple SclerosisMultiple SclerosisDrug: Duloxetine;Drug: PlaceboBrown, Theodore R., M.D., MPHEli Lilly and CompanyCompleted18 YearsN/AAll38Phase 2/Phase 3United States
1024NCT00420212
(ClinicalTrials.gov)
January 20078/1/2007Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple SclerosisA Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: BG00012;Drug: PlaceboBiogenNULLCompleted18 Years55 YearsAll1234Phase 3United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czech Republic;France;Germany;Greece;Guatemala;India;Israel;Italy;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Serbia;Slovakia;South Africa;Switzerland;Ukraine;United Kingdom;Virgin Islands (U.S.);Belarus;Bulgaria;Kazakhstan;Russian Federation;Sweden;Turkey
1025NCT00414453
(ClinicalTrials.gov)
January 200719/12/2006Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple SclerosisTrial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)Neuropathic Pain;Chronic Pain;Multiple SclerosisDrug: Lidocaine patch 5%;Drug: Extended-release oxycodone;Drug: Placebo extended-release oxycodone pills;Drug: Placebo lidocaine patchesUniversity of RochesterEndo PharmaceuticalsTerminated18 YearsN/AAll19Phase 4United States
1026EUCTR2006-002982-38-ES
(EUCTR)
13/12/200610/03/2010Ensayo 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, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
1027EUCTR2006-002633-20-ES
(EUCTR)
01/12/200613/04/2012Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrenteEstudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente Esclerosis múltiple remitente-recurrente
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline S.ANULLNot RecruitingFemale: yes
Male: yes
350Phase 2Finland;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Norway;New Zealand
1028NCT00428584
(ClinicalTrials.gov)
December 200629/1/2007RNF and Betaseron® Tolerability StudyA Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety ExtensionRelapsing Remitting Multiple Sclerosis (RRMS)Drug: New Formulation of rebif - human interferon beta-1a;Drug: Interferon beta -1bEMD SeronoPfizerCompleted18 Years60 YearsAll129Phase 3United States
1029NCT00441103
(ClinicalTrials.gov)
December 200626/2/2007A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple SclerosisA 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 SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Rebif® New Formulation (IFN-beta-1a, RNF);Drug: PlaceboMerck KGaANULLCompleted18 Years60 YearsAll180Phase 3Canada;Germany;Italy;Russian Federation;Spain;Switzerland
1030NCT00436826
(ClinicalTrials.gov)
November 30, 200615/2/2007A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-ß) Treatment in Multiple Sclerosis Subjects With Active DiseaseMultiple SclerosisDrug: Cladribine;Drug: Placebo;Drug: Interferon-beta (IFN-beta)EMD Serono Research & Development Institute, Inc.NULLCompleted18 Years65 YearsAll172Phase 2United States;Italy;Russian Federation;Spain
1031EUCTR2005-004061-41-HU
(EUCTR)
22/11/200620/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
1032NCT00370071
(ClinicalTrials.gov)
November 200629/8/2006Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple SclerosisOpen Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted16 Years55 YearsAll39Phase 3China
1033NCT00404352
(ClinicalTrials.gov)
November 200627/11/2006REbif FLEXible Dosing in Early Multiple Sclerosis (MS)A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Rebif New Formulation (44 Microgram [Mcg] Three Times Weekly [Tiw] and 44 Mcg Once Weekly [ow]) in Subjects at High Risk of Converting to Multiple Sclerosis (REFLEX)Multiple SclerosisDrug: RNF;Drug: PlaceboMerck KGaANULLCompleted18 Years50 YearsAll517Phase 3Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czech Republic;Estonia;Finland;France;Germany;Greece;Israel;Italy;Latvia;Lebanon;Morocco;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Turkey;Denmark;Switzerland
1034EUCTR2005-004061-41-GR
(EUCTR)
31/10/200628/07/2006An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATAAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden
1035NCT00803049
(ClinicalTrials.gov)
October 20061/12/2008Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple SclerosisLong-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 RelapsesMultiple SclerosisDrug: Teriflunomide (HMR1726)SanofiNULLCompleted18 Years55 YearsAll742Phase 3United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
1036NCT00516893
(ClinicalTrials.gov)
October 200614/8/2007Natalizumab High Titer Immunogenicity and SafetyA Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: BG00002-E (natalizumab high titer)BiogenElan PharmaceuticalsCompleted18 Years55 YearsAll113Phase 2United States
1037NCT00781872
(ClinicalTrials.gov)
October 200628/10/2008Mesenchymal Stem Cells for the Treatment of MSExplorative Trial to Investigate the Safety and Clinical Effects of Autologous Mesenchymal Bone Marrow Stem Cells (MSC) Following Their Intrathecal and Intravenous Administration in Severe Cases of Multiple Sclerosis (MS)Multiple SclerosisBiological: Injection of autologous bone marrow derived mesenchymal stem cellsHadassah Medical OrganizationNULLCompleted35 Years65 YearsAll24Phase 1/Phase 2NULL
1038EUCTR2006-002037-20-ES
(EUCTR)
06/09/200607/07/2006 A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: Glatiramer acetato
Trade Name: Copaxone 20 mg/ml solución para inyección en jeringa precargada
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: GLATIRAMERO ACETATO
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot Recruiting Female: yes
Male: yes
980 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom
1039NCT00391079
(ClinicalTrials.gov)
September 200620/10/2006Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MSA Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex When Added to the Existing Treatment Regimen, in the Relief of Central Neuropathic Pain in Subjects With Multiple SclerosisMultiple SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll339Phase 3Canada
1040NCT00261326
(ClinicalTrials.gov)
September 20062/12/2005Simvastatin Treatment of Patients With Acute Optic NeuritisSimvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III TrialOptic Neuritis;Multiple SclerosisDrug: simvastatin;Drug: placeboGlostrup University Hospital, CopenhagenAlpharma ApSActive, not recruiting18 Years59 YearsBoth64Phase 3Denmark
1041NCT00337779
(ClinicalTrials.gov)
August 200614/6/2006Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)Relapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate (GA) 40 mg;Drug: glatiramer acetate 20 mgTeva Pharmaceutical IndustriesNULLCompleted18 Years55 YearsAll1155Phase 3Argentina;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain;United Kingdom;United States
1042EUCTR2005-005592-14-DE
(EUCTR)
27/07/200612/05/2006Double blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision ProtectDouble blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision Protect Multiple sclerosis (MS) is a chronic disease of the central nervous system.Optic neuritis represents one of the most common and frequently the first clinical manifestation of MS. Optic neuritis is mainly characterized by a subacute loss of vision.Trade Name: Erypo/Erypo FS
Product Name: Erypo/Erypo FS
INN or Proposed INN: Epoetin alfa
Other descriptive name: Epo
Trade Name: Urbason solubile forte 1000mg
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolon-21-hydrogensuccinat, Natriumsalz
IFSgGmbH, Institute for clinical researchNULLNot RecruitingFemale: yes
Male: yes
Germany
1043EUCTR2005-004061-41-BE
(EUCTR)
17/07/200629/11/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
521Phase 3Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
1044NCT00501943
(ClinicalTrials.gov)
July 200612/7/2007Neuroprotection With Riluzole Patients With Early Multiple SclerosisNeuroprotection With Riluzole in Patients With Early Multiple SclerosisMultiple SclerosisDrug: Avonex (Interferon beta 1a);Drug: Riluzole;Drug: PlaceboUniversity of California, San FranciscoNational Multiple Sclerosis Society;Oregon Health and Science UniversityCompleted18 Years55 YearsAll43Phase 2United States
1045NCT00288626
(ClinicalTrials.gov)
July 20067/2/2006High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) StudyA 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 SclerosisRelapsing-Remitting Multiple SclerosisDrug: Granulocyte-colony stimulating factor (G-CSF) and prednisone;Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM);Procedure: Autologous hematopoietic stem cell transplantNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Completed18 Years60 YearsAll25Phase 2United States
1046NCT00638027
(ClinicalTrials.gov)
July 200610/3/2008Memantine for Spasticity in MS PatientsMemantine for Spasticity in MS PatientsMultiple SclerosisDrug: placebo;Drug: memantineUniversity of RochesterForest LaboratoriesCompleted18 Years70 YearsAll21Phase 4United States
1047EUCTR2005-001567-55-DE
(EUCTR)
23/06/200629/07/2005A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisA Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation.Product Name: Daclizumab
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
270Phase 2United Kingdom;Germany;Spain
1048EUCTR2005-004061-41-DK
(EUCTR)
19/06/200609/01/2006TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;New Zealand;Sweden
1049EUCTR2005-004061-41-GB
(EUCTR)
01/06/200625/10/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI 300 mg concentrate for solution for infusion
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot Recruiting Female: yes
Male: yes
458 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGreece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
1050NCT00648908
(ClinicalTrials.gov)
June 200628/3/2008Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 TrialPhase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 TrialMultiple SclerosisDrug: Fampridine-SRAcorda TherapeuticsNULLCompleted18 Years70 YearsAll269Phase 3United States;Canada
1051NCT00355134
(ClinicalTrials.gov)
June 200619/7/2006Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseMultiple SclerosisDrug: Fingolimod;Drug: PlaceboNovartisNULLCompleted18 Years55 YearsAll1083Phase 3United States;Australia;Austria;Canada;Poland;Romania;Turkey;United Kingdom;Lithuania
1052EUCTR2005-004061-41-DE
(EUCTR)
18/05/200614/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
521Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
1053NCT00340834
(ClinicalTrials.gov)
May 200619/6/2006Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseA 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 im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseMultiple SclerosisDrug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: Interferon ß-1a 30 µgNovartisNULLCompleted18 Years55 YearsAll1292Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Egypt;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico
1054NCT00297232
(ClinicalTrials.gov)
March 200627/2/2006Natalizumab (Tysabri) Re-Initiation of DosingAn Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety EvaluationRelapsing-Remitting Multiple SclerosisDrug: NatalizumabBiogenNULLTerminated18 YearsN/AAll1094Phase 3Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria
1055NCT00317941
(ClinicalTrials.gov)
March 200624/4/2006Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or RebifThe AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).Relapsing-remitting Multiple SclerosisDrug: Betaferon/Betaseron;Drug: RebifBayerNULLCompleted18 Years55 YearsAll220Phase 4France
1056NCT00306592
(ClinicalTrials.gov)
March 200631/1/2006Natalizumab Re-Initiation of DosingAn Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety EvaluationMultiple Sclerosis, Relapsing-RemittingBiological: BG00002 (natalizumab)BiogenElan PharmaceuticalsCompleted18 YearsN/AAll404Phase 3United States;Canada
1057EUCTR2005-004061-41-IT
(EUCTR)
24/02/200621/04/2006Extension study with Natalizumab for pts already pertecipated in studies C-1801 e 1802 to evaluate safety of treatmentAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA sclerosi multipla
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: Natalizumab
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
700Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Australia;Germany;New Zealand;Sweden
1058EUCTR2005-004061-41-FI
(EUCTR)
10/02/200601/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
1059NCT01134627
(ClinicalTrials.gov)
February 200628/5/2010Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS]A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline Versus Placebo as Add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44 Mcg Tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Minocycline;Drug: PlaceboMerck KGaANULLTerminated18 Years55 YearsAll305Phase 2Denmark
1060EUCTR2005-004061-41-CZ
(EUCTR)
26/01/200611/01/2006TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
1061EUCTR2005-004061-41-IE
(EUCTR)
20/01/200608/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
1062EUCTR2005-003930-16-SE
(EUCTR)
19/01/200621/11/2005A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBINA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a.
MedDRA version: 7.0;Level: PT;Classification code 10028425
Product Name: Simvastatin Alternova
INN or Proposed INN: Simvastatin
Biogen Idec A/SNULLNot RecruitingFemale: yes
Male: yes
380Finland;Sweden
1063EUCTR2005-003930-16-FI
(EUCTR)
05/01/200629/11/2005A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBINA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who have been prescribed treatment with Avonex.
MedDRA version: 7.0;Level: PT;Classification code 10028425
Trade Name: Simvastatin Alternova
Product Name: Simvastatin Alternova
INN or Proposed INN: Simvastatin
Biogen Idec A/SNULLNot RecruitingFemale: yes
Male: yes
380Finland;Sweden
1064NCT00289978
(ClinicalTrials.gov)
January 20069/2/2006Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisA 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: PlaceboNovartisNULLCompleted18 Years55 YearsAll1272Phase 3Australia;Belgium;Canada;Czech Republic;Finland;France;Germany;Greece;Israel;Lithuania;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom;Italy
1065EUCTR2005-001567-55-GB
(EUCTR)
14/12/200524/08/2005A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisA Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation.Product Name: Daclizumab
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
270Phase 2Spain;Austria;Germany;United Kingdom
1066EUCTR2005-003930-16-DK
(EUCTR)
09/12/200505/12/2005A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBINA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a.
MedDRA version: 7.0;Level: PT;Classification code 10028425
Product Name: Simvastatin Alternova
INN or Proposed INN: Simvastatin
Biogen Idec A/SNULLNot RecruitingFemale: yes
Male: yes
380Finland;Denmark;Sweden
1067NCT00745615
(ClinicalTrials.gov)
December 7, 20052/9/2008An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the DiseaseAn Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL)Relapsing Remitting Multiple SclerosisDrug: Laquinimod;Drug: PlaceboTeva Pharmaceutical Industries, Ltd.NULLTerminated18 Years50 YearsAll257Phase 2Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czech Republic
1068NCT01142466
(ClinicalTrials.gov)
December 200510/6/2010A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After MitoxantronePhase IV, Multicenter, Open Label, Randomized Study of Rebif® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After MitoxantroneMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1a (Rebif)Merck KGaAGesellschaft für Therapieforschung mbHCompleted18 Years60 YearsAll30Phase 4NULL
1069NCT00273364
(ClinicalTrials.gov)
November 16, 20055/1/2006Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized StudyHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyMultiple SclerosisProcedure: Hematopoietic Stem Cell Therapy;Drug: Standard treatment with a conventional drugNorthwestern UniversityUppsala University;Sheffield Teaching Hospitals NHS Foundation Trust;University of Sao PauloCompleted18 Years55 YearsAll110Phase 2United States
1070NCT00270816
(ClinicalTrials.gov)
November 200527/12/2005Interferon ß-1b Treatment by Cyclical AdministrationEffect of Cyclical Administration of Interferon ß-1b in Multiple Sclerosis - Comparison With Normal Dose.Multiple SclerosisDrug: Interferon-ß-1b;Drug: Interferon ß-1bS. Andrea HospitalItalian Multiple Sclerosis FoundationCompleted18 Years55 YearsAll60Phase 2/Phase 3Italy
1071EUCTR2005-001567-55-ES
(EUCTR)
18/10/200505/09/2005A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltipleA Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation.Product Name: Daclizumab
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody
Protein Design Labs, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United Kingdom;Germany;Spain
1072NCT00242268
(ClinicalTrials.gov)
October 200519/10/2005A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: SimvastatinAlabama Neurology Associates, PCBiogen IdecRecruiting18 Years55 YearsBoth30Phase 3United States
1073EUCTR2005-001567-55-AT
(EUCTR)
27/09/200523/08/2005A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisA Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation.Product Name: Daclizumab
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
270Phase 2Spain;Austria;Germany;United Kingdom
1074NCT00220506
(ClinicalTrials.gov)
September 200514/9/2005Fatigue Treatment Using ProvigilFatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple SclerosisAll Multiple Sclerosis PatientsDrug: ProvigilSheba Medical CenterNULLRecruiting18 Years55 YearsBoth50N/AIsrael
1075NCT00754832
(ClinicalTrials.gov)
September 200516/9/2008American Ginseng Treatment for Multiple Sclerosis Related FatigueA Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related FatigueMultiple SclerosisDrug: American ginseng extract HT-1001;Drug: placeboOregon Health and Science UniversityNational Multiple Sclerosis SocietyCompleted18 Years70 YearsAll56Phase 2United States
1076EUCTR2005-006071-12-IT
(EUCTR)
31/08/200509/05/2006Evaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCEEvaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCE MULTIPLE SCLEROSIS
MedDRA version: 6.1;Level: PT;Classification code 10028245
Trade Name: EPARMEFOLIN 30 CPR 0,1/0,5MG
INN or Proposed INN: CALCIO FOLINATO DC.IT
INN or Proposed INN: CIANOCOBALAMINA FU DC.IT
Trade Name: LEVOFOLENE 4 MG 30 CPR
INN or Proposed INN: Calcium levofolinate
AZIENDA OSPEDALIERA SAN CAMILLO FORLANININULLNot RecruitingFemale: yes
Male: yes
276Italy
1077NCT00239993
(ClinicalTrials.gov)
August 200522/9/2005A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.Multiple SclerosisDrug: glatiramer acetate;Procedure: Warm compress prior to injection of glatiramer acetateTeva Neuroscience, Inc.NULLCompleted18 Years55 YearsAll50Phase 4United States
1078NCT00122954
(ClinicalTrials.gov)
July 200520/7/2005Fish Oil for the Treatment of Depression in Patients With Multiple SclerosisFish Oil as an Adjunct Therapy for Depression in Multiple SclerosisMultiple Sclerosis;DepressionDrug: Fish oil concentrate;Drug: PlaceboOregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH)Completed18 Years85 YearsAll39Phase 1/Phase 2United States
1079NCT01450488
(ClinicalTrials.gov)
June 20056/10/2011Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple SclerosisA Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple SclerosisMultiple SclerosisDrug: masitinibAB ScienceNULLCompleted18 Years60 YearsAll35Phase 2NULL
1080NCT00094172
(ClinicalTrials.gov)
May 200514/10/2004Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin in Patients With Clinically Isolated Syndrome and High Risk of Conversion to Multiple Sclerosis (ITN020AI)Multiple SclerosisDrug: Atorvastatin;Drug: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Completed18 Years55 YearsAll82Phase 2United States;Canada
1081NCT00127530
(ClinicalTrials.gov)
May 20054/8/2005Study of Oral Fampridine-SR in Multiple SclerosisDouble-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple SclerosisMultiple SclerosisDrug: Fampridine-SR;Drug: PlaceboAcorda TherapeuticsNULLCompleted18 Years70 YearsAll300Phase 3United States;Canada
1082NCT00213135
(ClinicalTrials.gov)
April 200513/9/2005A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: Cladribine 5.25 mg/kg;Drug: Cladribine 3.5 mg/kg;Other: PlaceboEMD SeronoNULLCompleted18 Years65 YearsAll1326Phase 3Canada;Switzerland
1083NCT01599234
(ClinicalTrials.gov)
March 200510/5/2012A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple SclerosisA Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis.Multiple SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll337Phase 3United Kingdom
1084NCT00211887
(ClinicalTrials.gov)
January 200513/9/2005Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRxA Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)Relapsing Remitting Multiple SclerosisDrug: Interferon beta 1-a;Drug: glatiramer acetate;Other: placeboFred LublinNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 Years60 YearsAll1008Phase 3United States;Canada
1085NCT00203047
(ClinicalTrials.gov)
January 200513/9/2005Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer AcetateA Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA)Relapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Placebo;Drug: PrednisoneTeva Pharmaceutical IndustriesNULLTerminated18 Years55 YearsAll414Phase 4Canada;United States
1086NCT01201343
(ClinicalTrials.gov)
January 200513/9/2010Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis PatientsEvaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis PatientsMultiple Sclerosis, Relapsing, RemittingDrug: Interferon beta-1aMerck KGaAMerck Serono S.A.S, FranceCompleted18 YearsN/AAll79Phase 4NULL
1087NCT00110396
(ClinicalTrials.gov)
January 20056/5/2005Rebif New Formulation (RNF) in Relapsing Forms of Multiple SclerosisA Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: Interferon-beta-1a FBS-free/HSA-freeEMD SeronoPfizerCompleted18 Years60 YearsAll260Phase 3United States
1088EUCTR2004-000663-99-HU
(EUCTR)
08/11/200408/09/2004Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate
Biogen Idec Inc.Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
260Hungary;Sweden
1089EUCTR2004-000663-99-CZ
(EUCTR)
12/10/200422/10/2004Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate
Biogen Idec Inc.Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
260Hungary;Czech Republic;Sweden
1090EUCTR2004-000663-99-SE
(EUCTR)
10/09/200403/08/2004Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate
Biogen Idec Inc.Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
260Hungary;Sweden
1091NCT00134563
(ClinicalTrials.gov)
September 200423/8/2005Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide)SanofiNULLCompleted18 Years55 YearsAll1088Phase 3United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
1092NCT00220922
(ClinicalTrials.gov)
August 200420/9/2005A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®Multiple SclerosisProcedure: Alcohol Wipes vs. No Alcohol WipesTeva Neuroscience, Inc.NULLCompleted18 YearsN/ABoth50Phase 4United States
1093NCT00103974
(ClinicalTrials.gov)
July 200417/2/2005Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple SclerosisA Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple SclerosisMultiple SclerosisBiological: BHT-3009-01Bayhill TherapeuticsNULLCompleted18 Years65 YearsBoth30Phase 1United States;Canada
1094NCT00207727
(ClinicalTrials.gov)
July 200413/9/2005A Safety and Efficacy Study of CNTO1275 in Patients With Multiple SclerosisA Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: CNTO 1275Centocor, Inc.Centocor BVCompleted18 Years65 YearsAll249Phase 2Australia;Canada;Czech Republic;Hungary;Poland;United Kingdom;United States
1095EUCTR2004-000374-31-IT
(EUCTR)
09/06/200426/08/2004A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple SclerosisA Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple Sclerosis Relapsing Multiple SclerosisTrade Name: ALTRI FARMACI DEL SISTEMA NERVOSO
Product Name: NA
Product Code: aSB-683699
GLAXO SMITHKLINENULLNot RecruitingFemale: yes
Male: yes
Italy
1096NCT00087529
(ClinicalTrials.gov)
June 20049/7/2004A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple SclerosisA Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple SclerosisMultiple SclerosisDrug: placebo;Drug: rituximabGenentech, Inc.NULLCompleted18 Years65 YearsAll439Phase 2/Phase 3Canada;United States
1097NCT00367484
(ClinicalTrials.gov)
May 200421/8/2006Study To Evaluate The Immunogenicity And Safety Of r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In Multiple SclerosisMulticentre, Single Arm, Open, Phase IV Study To Evaluate Immunogenicity And Safety Of Subcutaneous r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In The Treatment Of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisBiological: Rebif® (clone 484-39)Merck KGaANULLCompleted18 Years60 YearsAll460Phase 4NULL
1098NCT00682929
(ClinicalTrials.gov)
April 14, 200419/5/2008Cannabis for Spasticity in Multiple SclerosisCannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled StudyMultiple SclerosisDrug: Inhaled Cannabis;Drug: Oral THC;Drug: Oral Placebo;Drug: Inhaled placeboUniversity of California, DavisNational Multiple Sclerosis SocietyTerminated21 YearsN/AAll41Phase 1/Phase 2United States
1099NCT00300716
(ClinicalTrials.gov)
April 20048/3/2006Trial of Memantine for Cognitive Impairment in Multiple SclerosisDouble Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple SclerosisMultiple Sclerosis;Cognition DisordersDrug: MemantineOregon Health and Science UniversityForest Laboratories;University of Southern California;University of Texas Southwestern Medical Center;MS-Hub SeattleCompleted18 Years65 YearsAll82Phase 2/Phase 3United States
1100NCT00666224
(ClinicalTrials.gov)
January 200422/4/2008Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated SyndromeA Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS)Multiple SclerosisDrug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL)Teva Pharmaceutical IndustriesNULLCompleted18 Years45 YearsAll481Phase 3Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States
1101NCT00246324
(ClinicalTrials.gov)
December 200327/10/2005Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple SclerosisAn Open Label Trial of Safety and Efficacy of Combination Therapy With Interferon-B-1a and Oral Doxycycline in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Interferon beta 1a, oral doxycyclineLouisiana State University Health Sciences Center ShreveportBiogenCompleted18 Years55 YearsAll16Phase 4United States
1102NCT00654927
(ClinicalTrials.gov)
November 20034/4/2008Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple SclerosisPhase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple SclerosisMultiple SclerosisDrug: Fampridine-SR b.i.d. (Twice Daily)Acorda TherapeuticsNULLCompleted18 Years70 YearsAll177Phase 3United States;Canada
1103NCT00071838
(ClinicalTrials.gov)
October 30, 200331/10/2003Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple SclerosisZenapax (Daclizumab) Admin to Pts With Multiple Sclerosis (ZAP MS): Effect of Intravenously Admin Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (Daclizumab) on Inflammatory Activity in the Central Nervous SystemMultiple Sclerosis, Relapsing-RemittingDrug: DaclizumabNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 Years65 YearsAll16Phase 2United States
1104NCT00616187
(ClinicalTrials.gov)
October 20035/2/2008Atorvastatin in Relapsing-Remitting Multiple SclerosisOral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: interferon beta treatment to add-on atorvastatin treatment;Drug: untreated to atorvastatin treatmentCharite University, Berlin, GermanyGerman Research Foundation;German Federal Ministry of Education and Research;PfizerCompleted18 Years55 YearsAll41Phase 2NULL
1105NCT00242177
(ClinicalTrials.gov)
October 200318/10/2005Pilot Test of ACTOS in Multiple Sclerosis: Safety and TolerabilityPilot Test of ACTOS in Multiple Sclerosis: Safety and TolerabilityMultiple Sclerosis, Relapsing-RemittingDrug: ACTOS (Pioglitazone)University of Illinois at ChicagoTakeda Pharmaceuticals North America, Inc.Completed18 Years65 YearsAll30Phase 1United States
1106NCT00418145
(ClinicalTrials.gov)
September 20032/1/2007Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis AttacksOral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)Multiple SclerosisDrug: megadose oral methylprednisolone;Drug: IV methylprednisoloneFred LublinNational Multiple Sclerosis Society;PfizerTerminated18 Years50 YearsAll16Phase 3United States
1107NCT00276341
(ClinicalTrials.gov)
August 200312/1/2006Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple SclerosisEfficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.Multiple Sclerosis, Relapsing-RemittingDrug: EGb 761® (Tanakan®)IpsenNULLCompleted18 YearsN/AAll240Phase 3France
1108NCT00079495
(ClinicalTrials.gov)
July 20038/3/2004Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: NBI-5788Neurocrine BiosciencesImmune Tolerance Network (ITN)Completed18 Years55 YearsBoth150Phase 2NULL
1109NCT00203073
(ClinicalTrials.gov)
June 200313/9/2005A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantroneTeva Pharmaceutical IndustriesNULLCompleted18 Years55 YearsBoth40Phase 2United States;Canada
1110NCT00278655
(ClinicalTrials.gov)
June 200316/1/2006Hematopoietic Stem Cell Therapy for Patients With Multiple SclerosisHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Interferon Therapy: A Phase II Multi-Center TrialMultiple SclerosisBiological: Hematopoietic stem cell transplantationNorthwestern UniversityNULLTerminated18 Years50 YearsAll21Phase 1/Phase 2United States
1111NCT00235989
(ClinicalTrials.gov)
June 200310/10/2005Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple SclerosisAn Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: Interferon beta 1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years55 YearsAll63Phase 2United States
1112NCT00333138
(ClinicalTrials.gov)
May 20031/6/2006Efficacy and Safety of FTY720 in Patients With Relapsing Multiple SclerosisDouble-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension PhaseMultiple SclerosisDrug: FTY720;Drug: PlaceboNovartisNULLCompleted18 Years60 YearsAll281Phase 2Canada;Denmark;Finland;France;Germany;Italy;Poland;Portugal;Spain;Switzerland;United Kingdom
1113NCT00095329
(ClinicalTrials.gov)
May 20032/11/2004Treating Multiple Sclerosis With Sirolimus, an Immune System SuppressorA Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple SclerosisMultiple Sclerosis (MS) - Relapsing-remittingBiological: sirolimusNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceTerminated18 Years58 YearsBoth14Phase 1/Phase 2United States
1114NCT00053417
(ClinicalTrials.gov)
February 200329/1/2003Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple SclerosisDouble-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)Acorda TherapeuticsNULLCompleted18 Years70 YearsAll206Phase 2United States;Canada
1115NCT00076934
(ClinicalTrials.gov)
January 20036/2/2004Safety of RG2077 in Patients With Multiple SclerosisA Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: RG2077 (CTLA4-IgG4m)National Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Repligen CorporationCompleted18 Years55 YearsAll20Phase 1United States
1116NCT00220779
(ClinicalTrials.gov)
December 200213/9/2005Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple SclerosisRandomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)Grifols Therapeutics Inc.NULLCompleted18 Years55 YearsAll128Phase 2United States;Austria;Canada;Czech Republic;Germany;Greece;Hungary;Israel;Poland;Slovakia;Sweden;United Kingdom
1117NCT00050778
(ClinicalTrials.gov)
December 200219/12/2002A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple SclerosisA Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: Interferon beta-1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mgGenzyme, a Sanofi CompanyBayerCompleted18 Years50 YearsAll334Phase 2United States;Croatia;Poland;Russian Federation;United Kingdom
1118NCT00678795
(ClinicalTrials.gov)
August 200214/5/2008A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple SclerosisA Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis.Detrusor Overactivity;Multiple SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll135Phase 3United Kingdom
1119NCT00185211
(ClinicalTrials.gov)
August 20029/9/2005BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up StudyOpen-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years48 YearsAll468Phase 3Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom
1120NCT00587691
(ClinicalTrials.gov)
July 200221/12/2007Dose-Escalation Study of T Cell Vaccine in Multiple SclerosisAn Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary ProgressiveBiological: Tovaxin Autologous T Cell VaccineOpexa Therapeutics, Inc.NULLCompleted18 Years65 YearsAll16Phase 1/Phase 2United States
1121NCT00711646
(ClinicalTrials.gov)
June 20028/7/2008A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis.Spasticity;Multiple SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll189Phase 3United Kingdom
1122NCT00037115
(ClinicalTrials.gov)
May 200215/5/2002Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event.An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results.Demyelinating Disorders;Multiple Sclerosis;Optic Neuritis;Myelitis;NeuritisDrug: interferon beta 1a;Drug: methotrexate;Drug: methylprednisoloneMidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteConsultants in NeurologyWithdrawn18 Years50 YearsAll0Phase 4United States
1123NCT01606176
(ClinicalTrials.gov)
March 200221/5/2012A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological OriginA Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function.Pain;Multiple SclerosisDrug: GW-1000-02;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll70Phase 3United Kingdom
1124NCT01604265
(ClinicalTrials.gov)
March 200221/5/2012A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple SclerosisA Double Blind, Randomised, Parallel Group, Placebo Controlled Study of Sativex in the Treatment of Central Neuropathic Pain in Multiple Sclerosis.Multiple Sclerosis;Neuropathic PainDrug: Placebo;Drug: SativexGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll66Phase 3United Kingdom
1125NCT01606137
(ClinicalTrials.gov)
February 200221/5/2012A Study of the Long-term Safety of Sativex UseA Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine.Multiple Sclerosis;Spasticity;PainDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll507Phase 3United Kingdom
1126NCT00027300
(ClinicalTrials.gov)
November 200130/11/2001Safety and Efficacy of Natalizumab in the Treatment of Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogenElan PharmaceuticalsCompleted18 Years50 YearsAll900Phase 3United States;Belgium;Canada;Czech Republic;France;Germany;Netherlands;United Kingdom
1127NCT00039988
(ClinicalTrials.gov)
November 200118/6/2002Treatment of Multiple Sclerosis With Copaxone and AlbuterolTreatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate) and AlbuterolAutoimmune Diseases;Multiple SclerosisDrug: Glatiramer acetate;Drug: Albuterol;Drug: Albuterol placeboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceCompleted18 Years55 YearsBoth40N/AUnited States
1128NCT00037102
(ClinicalTrials.gov)
July 200115/5/2002Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple SclerosisAn Open Label Study of the Safety and Efficacy of Combination Therapy With AVONEX and Bi-Monthly High Dose Intravenous Methotrexate With Leucovorin Rescue in the Treatment of Multiple SclerosisMultiple SclerosisDrug: interferon beta 1a;Drug: methotrexateMidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteConsultants in Neurology;BiogenCompleted18 Years60 YearsAll16Phase 4United States
1129NCT01610687
(ClinicalTrials.gov)
July 200131/5/2012A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisA Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple Sclerosis;SpasticityDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll137Phase 3United Kingdom
1130NCT01610700
(ClinicalTrials.gov)
May 200131/5/2012An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis PatientsDouble Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple SclerosisDrug: GW-1000-02;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll160Phase 3United Kingdom
1131NCT01610713
(ClinicalTrials.gov)
May 200131/5/2012An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisDouble Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple SclerosisDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll154Phase 3United Kingdom
1132NCT00179478
(ClinicalTrials.gov)
February 200112/9/2005Long Term Study of Avonex Therapy Following a First Attack of Multiple SclerosisControlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)Multiple Sclerosis;Optic Neuritis;Transverse Myelitis;Acute Brainstem/Cerebellar SyndromeDrug: interferon beta 1a 30 ug IM once weeklyBeth Israel Deaconess Medical CenterBiogenCompleted18 YearsN/AAll155Phase 4United States;Canada
1133NCT00062972
(ClinicalTrials.gov)
September 199918/6/2003Improving Memory in Patients With Multiple SclerosisInterventions to Improve Memory in Patients With Multiple SclerosisMultiple SclerosisDrug: donepezil;Drug: glucoseEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)U.S. Department of EducationWithdrawn18 Years56 YearsAll0Phase 3United States
1134NCT00010842
(ClinicalTrials.gov)
September 19992/2/2001Natural Antioxidants in the Treatment of Multiple SclerosisNatural Antioxidants in the Treatment of Multiple SclerosisMultiple SclerosisDrug: Ginkgo biloba;Drug: Alpha-lipoic acid;Drug: Vitamin E/Selenium;Drug: Essential fatty acidsNational Center for Complementary and Integrative Health (NCCIH)NULLCompletedN/AN/ABothPhase 1/Phase 2United States
1135NCT00001934
(ClinicalTrials.gov)
September 19993/11/1999Zenapax to Treat Multiple SclerosisEffect of the Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (IL-2R-Alpha; Zenapax(Registered Trademark)) on Inflammatory Activity in the CNS in MS in a Baseline-to-Treatment, Cross-Over, MRI-Controlled Single Center Phase I/II TrialMultiple SclerosisDrug: ZenapaxNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 Years65 YearsBoth22Phase 2United States
1136NCT00040482
(ClinicalTrials.gov)
April 199926/6/2002High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple SclerosisIntensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple SclerosisMultiple SclerosisDrug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapyBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineCompleted18 Years60 YearsAll10Phase 2United States
1137NCT04472975
(ClinicalTrials.gov)
January 1, 19963/7/2020Prescription Drug Safety and Effectiveness in Multiple SclerosisDisease-modifying Drug Safety and Effectiveness in Multiple Sclerosis [DRUMS]Multiple SclerosisDrug: Exposure to one or more disease-modifying drug(s)(DMDs) used to treat MSUniversity of British ColumbiaUniversity of Manitoba;Dalhousie University;University of Saskatchewan;Alberta Health Services;University of AlbertaCompleted18 YearsN/AAll35000NULL
1138NCT00203021
(ClinicalTrials.gov)
March 26, 199412/9/2005Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and EffectivenessOpen Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With CopaxoneRelapsing-Remitting Multiple SclerosisDrug: Glatiramer acetateTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 YearsN/AAll208Phase 4United States
1139EUCTR2016-003100-30-Outside-EU/EEA
(EUCTR)
16/06/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNAFemale: yes
Male: yes
65Phase 3Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Greece;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation
1140EUCTR2016-003100-30-BG
(EUCTR)
02/06/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
1141EUCTR2016-003100-30-FR
(EUCTR)
17/07/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNAFemale: yes
Male: yes
65Phase 3Sweden;Germany;Netherlands;Norway;Bulgaria;Belgium;Poland;Czech Republic;France;Italy;United Kingdom;Switzerland;Russian Federation;Austria;Turkey;Spain;Greece;Portugal
1142EUCTR2016-003100-30-PL
(EUCTR)
21/07/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
1143EUCTR2009-016442-74-ES
(EUCTR)
22/12/2009Trasplante autólogo de células madre mesenquimales en esclerosis múltiple: ensayo clínico fase II aleatorizado, enmascarado y cruzado con placebo.Trasplante autólogo de células madre mesenquimales en esclerosis múltiple: ensayo clínico fase II aleatorizado, enmascarado y cruzado con placebo. Esclerosis Múltiple
MedDRA version: 9;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive
Product Name: Células madre mesenquimales
INN or Proposed INN: Células madre mesenquimales
Fundació Clínic per a la Recerca BiomèdicaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain