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 13. 多発性硬化症/視神経脊髄炎 [臨床試験数:1,398,薬物数:1,427(DrugBank:306),標的遺伝子数:194,標的パスウェイ数:85] 

Searched query = "Multiple sclerosis", "Neuromyelitis optica", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1NCT02912897September 202022 October 2019Trial 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 HospitalNot recruiting18 Years45 YearsAll7Phase 1France
2NCT03404388April 1, 202029 July 2019Brain and Behavioral Influences on Motor Skill Learning in Multiple SclerosisBrain and Behavioral Influences on Motor Skill Learning in Multiple SclerosisMultiple SclerosisBehavioral: Balance TrainingWayne State UniversityRecruiting18 Years65 YearsAll150N/AUnited States
3NCT04150549February 202011 November 2019FMT for MS PatientsFecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized TrialMultiple SclerosisBiological: Fecal Microbial TransplantsLawson Health Research InstituteNot recruiting18 Years55 YearsAll34Phase 2
4NCT04140305January 5, 20204 November 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-1063CelgeneNot recruiting18 Years65 YearsAll250Phase 3
5NCT04079088December 23, 20197 October 2019Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) 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 Therapies in Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Placebo;Drug: BIIB061;Biological: Interferon-beta1BiogenNot recruiting18 Years55 YearsAll300Phase 2
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6NCT04075266December 11, 20194 November 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 RocheNot recruiting10 Years18 YearsAll12Phase 2United States;Italy
7NCT04130997December 201911 November 2019An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple SclerosisTG1101-RMS303 is an Open-label, Single-arm Extension Study Designed to Evaluate Long-term Safety and Efficacy of Ublituximab in Subjects With Relapsing Multiple Sclerosis. Subjects Who Complete the 96-week, Double-blind Treatment Period o TG1101-RMS301 or TG1101-RMS302 Are Eligible for Participation in This Open Label Extension (OLE) Study.Relapsing Multiple Sclerosis (RMS)Biological: UblituximabTG Therapeutics, Inc.Not recruiting18 YearsN/AAll1000Phase 3
8NCT04025554November 13, 201911 November 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)Recruiting18 Years100 YearsAll10Phase 1/Phase 2United States
9NCT04146285November 5, 20194 November 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 SolutionsNot recruiting18 Years65 YearsAll48Phase 1China
10NCT03829566November 201911 November 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 UniversityNot recruiting18 Years65 YearsAll0Phase 2/Phase 3United States
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11NCT03983720November 201928 October 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 EtienneNot recruiting18 Years70 YearsAll60Phase 2France
12NCT04038541November 201928 October 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 UniversityRecruiting18 YearsN/AAll20N/AUnited States
13NCT04047628November 20194 November 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)Not recruiting18 Years55 YearsAll156Phase 3United States;United Kingdom
14NCT04155424November 201911 November 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 PharmaceuticalsNot recruiting2 Years17 YearsAll15Phase 2/Phase 3United States;Canada;Germany;Italy;Japan;Korea, Republic of;Spain
15NCT03958877October 31, 201922 October 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 1aBiogenRecruiting10 Years18 YearsAll142Phase 3United States;Bulgaria;Czechia;France;Italy;Spain;Greece
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16NCT04096443October 14, 201930 September 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
17NCT04129736October 10, 201928 October 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 LyckeRecruiting18 Years65 YearsAll20Phase 4Sweden
18NCT04115488October 1, 201911 November 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.Recruiting18 Years60 YearsAll260Phase 3Poland
19NCT03963375October 201914 October 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
20NCT04121403October 201922 October 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 NorwayRecruiting18 Years65 YearsAll264Phase 3Norway
No.TrialIDDate_
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21NCT04121468October 201922 October 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 MedicineNot recruiting10 Years18 YearsAll30Phase 1/Phase 2
22NCT04144257October 20194 November 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 HospitalUnited States Department of DefenseNot recruiting18 Years60 YearsAll12Phase 1/Phase 2United States
23NCT03807973September 30, 201930 September 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 BirminghamNot recruiting18 Years65 YearsAll120Phase 1
24NCT03996291September 23, 201914 October 2019Long Term Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple SclerosisLong-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: SAR442168SanofiRecruiting18 Years55 YearsAll105Phase 2United States
25NCT04035889September 23, 20197 October 2019Melatonin for Sleep in MSA Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)Multiple SclerosisDietary Supplement: Placebo;Dietary Supplement: MelatoninUniversity of California, San FranciscoRecruiting20 Years70 YearsAll30N/AUnited States
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26NCT04121221September 19, 201922 October 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.Recruiting18 Years55 YearsAll960Phase 3United States
27NCT04002934September 10, 201911 November 2019Bazedoxifene Acetate as a Remyelinating Agent in Multiple SclerosisA Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Delayed-Start Trial to Assess the Efficacy, Safety, and Tolerability of Bazedoxifene Acetate (BZA) as a Remyelinating Agent in Patients With Multiple SclerosisMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Bazedoxifene AcetateRiley Bove, MDRecruiting40 Years65 YearsFemale50Phase 2United States
28ChiCTR19000257442019-09-0130 September 2019Clinical effectiveness and safety of Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trialClinical effectiveness and safety Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trialneuromyelitis optica spectrum disorder (NMOSD)1:Intravenous 200mg Rituximab, 1/week*2, if the proportion of CD19+ B lymphocytes in peripheral blood is above 1% then repeat administration (200mg);2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (750~3000mg/day);The Ophthalmology Department of the Chinese Peoples Liberation Army HospitalRecruiting1870Both1:30;2:30;Phase 4China
29NCT03993171September 201916 September 201931P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis (REPAIR-MS)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 SclerosisRelapsing Remitting Multiple SclerosisDrug: gold nanocrystalsClene NanomedicineUniversity of Texas Southwestern Medical CenterNot recruiting18 Years55 YearsAll24Phase 2United States
30NCT04032158August 26, 201911 November 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, GermanyRecruiting18 Years55 YearsAll950Phase 3United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Mexico;Montenegro;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine;United Kingdom
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31NCT04032171August 19, 201929 July 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, GermanyNot recruiting18 Years55 YearsAll950Phase 3United States;Germany
32NCT03961204August 15, 201922 October 2019Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis (MS)Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsMultiple SclerosisDrug: CladribineEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 Years65 YearsAll971Phase 4United States;Georgia;Korea, Republic of;Germany
33NCT03972306August 12, 201928 October 2019A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients 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 RocheRecruiting18 Years65 YearsAll135Phase 1United States
34NCT04035005August 12, 201922 October 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 RocheRecruiting18 Years65 YearsAll1000Phase 3United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Egypt;France;Georgia;Germany;Hungary;Ireland;Italy;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
35JPRN-JapicCTI-19483831/7/201910 September 2019Investigation for immune response against JC virus in Multiple Sclerosis patients on treatment with fingolimodA 18-month, multicenter, two-cohort, prospective, observational study to investigate immune response against JC virus in Multiple Sclerosis patients on treatment with 0.5 mg fingolimod (FTY720)Multiple SclerosisIntervention name : Gilenya / Imusera
INN of the intervention : Fingolimod
Dosage And administration of the intervention : 0.5mg/day Fingolimod orally
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Novartis Pharma K.K.Mitsubishi Tanabe Pharma CorporationRecruiting18BOTH280NAJapan
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36NCT03933202July 22, 201922 October 2019A Study of Suboptimally Controlled Participants Previously Taking Oral Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS)Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Oral Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (MASTER-2)Multiple SclerosisDrug: Cladribine TabletsEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 YearsN/AAll200N/AUnited States
37NCT04022473July 7, 201929 July 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 LLCRecruiting18 Years65 YearsAll200Phase 1United States
38NCT03983252July 201924 June 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 recruiting18 Years60 YearsAll10Phase 1/Phase 2United States
39NCT03656627June 27, 201922 October 2019Nivolumab 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 SquibbRecruiting18 YearsN/AAll72Phase 1United States
40NCT03774407June 20, 20192 September 2019Vaginal Estriol in Multiple SclerosisDual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS)Multiple Sclerosis;Neurogenic BladderDrug: vaginal estriolTexas Tech University Health Sciences CenterRecruiting40 Years65 YearsFemale20Phase 2/Phase 3United States
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41NCT03887065June 15, 201920 May 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, MDNot recruiting18 Years55 YearsAll15Early Phase 1
42NCT03995810June 15, 201915 July 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 EducationCarnoMedRecruiting18 Years65 YearsAll3N/ASerbia
43NCT03873389June 12, 201915 July 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.Recruiting18 Years75 YearsAll50Phase 1United States
44NCT03783416June 1, 201921 January 2019SIZOMUS 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 recruiting18 Years65 YearsAll72Phase 1United Kingdom
45NCT03910738June 201923 April 2019TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple SclerosisTOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection;Drug: Placebo 4 mL Solution for Injection;Procedure: MRI;Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities;Behavioral: Assessment of disabilityUniversity Hospital, Strasbourg, FranceBayer;Fédération Hospitalo-Universitaire NEUROGENYCSNot recruiting18 Years55 YearsMale40Phase 2France
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46NCT03933215May 21, 201922 October 2019A Study of Suboptimally Controlled Participants Previously Taking Injectable Disease-modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS)Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Injectable Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (CLICK-MS)Multiple SclerosisDrug: Cladribine TabletsEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 YearsN/AAll200N/AUnited States
47NCT03824938April 30, 201915 July 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)Recruiting18 Years65 YearsAll60Phase 1/Phase 2United States
48NCT03816345April 4, 201911 November 2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)Recruiting18 YearsN/AAll264Phase 1United States
49NCT03025269April 2, 201929 April 2019Ocrelizumab 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 BuffaloRecruiting18 Years60 YearsAll30N/AUnited States
50NCT03853746April 1, 201927 May 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 SocietyRecruiting18 Years99 YearsAll10Phase 4United States
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51NCT03888924April 1, 20191 April 2019Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)Multiple SclerosisDrug: Placebo;Drug: Bacille Calmette-Guerin vaccineS. Andrea HospitalNot recruiting18 YearsN/AAll100Phase 2Italy
52NCT02466074April 201919 November 2018Augmenting 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, HoustonNot recruiting18 Years55 YearsAll60Phase 2United States
53NCT03856619March 27, 201915 April 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 HMR1726SanofiRecruiting18 YearsN/AAll193Phase 4India
54NCT03945006March 25, 201920 May 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 UniversityNot recruiting24 Years58 YearsAll36N/ATurkey
55NCT03870763March 19, 201928 October 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: PlaceboBiogenRecruiting10 Years17 YearsAll340Phase 3United States;Colombia;Estonia;Hungary;Korea, Republic of;Taiwan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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56EUCTR2018-003927-12-SK18/03/201930 April 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 Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10067063 Term: Progressive relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not available
CAS Number: 1971920-73-6
Current Sponsor code: SAR442168
Other descriptive name: PRN2246
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
INN or Proposed INN: Not available
CAS Number: 1971920-73-6
Current Sponsor code: SAR442168
Other descriptive name: PRN2246
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Genzyme CorporationAuthorised Female: yes
Male: yes
160Phase 2France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
57NCT03799718March 13, 201926 August 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 TherapeuticsRecruiting18 Years65 YearsAll20Phase 2United States
58EUCTR2018-000516-22-HU04/03/201930 April 2019Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 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 SclerosisRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TECFIDERA
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: PEGINTERFERON BETA-1A
CAS Number: 1211327-92-2
Current Sponsor code: BIIB017
Other descriptive name: PEGINTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: up to
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Biogen Idec Research LimitedAuthorised Female: yes
Male: yes
340Phase 3Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
59NCT03896217March 20198 April 2019Simvastatin 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 SocietyNot recruiting18 Years65 YearsAll40Phase 2United Kingdom
60NCT03737812February 27, 20194 November 2019A 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: placeboAbbVieRecruiting18 Years65 YearsAll90Phase 2United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
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PhaseCountries
61NCT03808142February 20, 20194 November 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, BAY 86-5046;Device: BETACONNECTBayerRecruiting18 YearsN/AAll200Phase 2Germany
62NCT03756974February 18, 201911 November 2019BX-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 SERecruiting18 Years65 YearsAll384Phase 3Czechia;Germany;Hungary;Poland;Spain
63NCT03752307February 15, 201913 May 2019Safety 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 MexicoRecruiting18 Years50 YearsAll20Phase 1/Phase 2United States
64NCT03623243February 14, 20198 April 2019Safety and Tolerability of Conversion From Oral or Injectable Disease Modifying Therapies to Dose-titrated Oral Siponimod in Advancing RMS Patients.Exploring the Safety and Tolerability of Conversion From Oral or Injectable Disease Modifying Therapies to Dose-titrated Oral Siponimod in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb StudyMultiple Sclerosis, Relapsing MS, Advancing Multiple SclerosisDrug: SiponimodNovartis PharmaceuticalsRecruiting18 Years65 YearsAll300Phase 3United States
65NCT03822858February 12, 201930 September 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 YorkNot recruiting18 Years70 YearsAllPhase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
66NCT03759522February 3, 20198 April 2019Assessment 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 BirminghamRecruiting18 Years65 YearsAll120Phase 1United States
67NCT03784547February 1, 201926 August 2019Real-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 AiresRecruitingN/AN/AAll100N/AArgentina
68NCT03825601February 1, 201911 February 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, FranceNot recruiting18 Years55 YearsAll45N/A
69NCT03846219January 28, 20194 March 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 AGRecruiting18 Years55 YearsAll195Phase 2Bulgaria
70NCT03653273January 24, 201918 March 2019Disease 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 SclerosisDrug: DMT continuation;Other: DMT withdrawalRennes University HospitalRecruiting50 YearsN/AAll250Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
71NCT03745144January 17, 201928 October 2019Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon®A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the Pharmacokinetics of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With Relapsing Multiple Sclerosis (RMS).Relapsing Multiple Sclerosis (RMS)Drug: Cladribine;Drug: Placebo;Drug: Microgynon®Merck KGaA, Darmstadt, GermanyRecruiting18 Years45 YearsFemale34Phase 1Germany;Poland
72NCT04086225January 17, 201916 September 2019Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon®A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the Pharmacokinetics of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With Relapsing Multiple Sclerosis (RMS).Relapsing Multiple Sclerosis (RMS)Drug: Cladribine;Drug: Placebo;Drug: Microgynon®Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, GermanyRecruiting18 Years45 YearsFemale34Phase 1Germany;Poland
73EUCTR2018-000516-22-EE14/01/201928 February 2019Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 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 SclerosisRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TECFIDERA
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: PEGINTERFERON BETA-1A
CAS Number: 1211327-92-2
Current Sponsor code: BIIB017
Other descriptive name: PEGINTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: up to
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Biogen Idec Research LimitedAuthorised Female: yes
Male: yes
340Phase 3Serbia;Portugal;United States;Saudi Arabia;Estonia;Taiwan;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
74EUCTR2017-004886-29-IE11/01/201928 February 2019A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA 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 TRIALMultiple sclerosis (MS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F. Hoffmann-La Roche LtdAuthorised Female: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
75NCT03803800January 9, 201928 January 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 UniversityRecruiting18 Years75 YearsAll80N/ABelgium
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
76NCT03535298January 3, 201926 August 2019Determining 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
77NCT04106830January 1, 201922 October 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 HospitalRecruiting16 Years80 YearsAll1000N/AChina
78NCT03650114December 28, 201814 October 2019Long-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 PharmaceuticalsRecruiting18 YearsN/AAll2010Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom
79NCT03847545December 12, 201811 March 2019Muscle 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;University of Miami;Region of Southern Denmark;The Augustinus Foundation, Denmark.;The Lounkaer Foundation;Fonden for scleroseramte paa Fyn;The Danish Multiple Sclerosis Society;The Lily Benthine Lunds FoundationRecruiting18 Years100 YearsAll60N/ADenmark
80NCT03737851December 11, 20184 November 2019A 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: placeboAbbVieRecruiting18 Years65 YearsAll165Phase 2United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
81EUCTR2018-002315-98-DK06/12/201830 April 2019The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury.The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCICentral neuropathic pain and spasticity
MedDRA version: 20.0 Level: PT Classification code 10028335 Term: Muscle spasticity System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: LLT Classification code 10077975 Term: Central neuropathic pain System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol capsule 5 mg
Product Code: N/A
Pharmaceutical Form: Capsule
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Other descriptive name: CBD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Dronabinol capsule 2,5 mg
Product Code: N/A
Pharmaceutical Form: Capsule
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3
Other descriptive name: THC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg
Product Code: N/A
Pharmaceutical Form: Capsule
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3
Other descriptive name: THC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Other descriptive name: CBD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Aarhus UniversitetshospitalAuthorised Female: yes
Male: yes
448Phase 2Denmark
82NCT03944447December 1, 20187 October 2019Outcomes Mandate National Integration With Cannabis as MedicineOutcomes Mandate National Integration With Cannabis as MedicineChronic 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 DisorderDrug: Cannabis, MedicalOMNI Medical Services, LLCRecruiting7 YearsN/AAll100000Phase 2United States
83NCT03689972November 28, 20187 October 2019A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID TreatmentA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID TreatmentMultiple Sclerosis, Relapsing-RemittingDrug: NatalizumabBiogenNot recruiting18 Years60 YearsAll480Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom
84NCT03536559November 23, 201828 January 2019Nanocrystalline 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 LtdRecruiting18 Years50 YearsAll150Phase 2Australia
85EUCTR2017-004703-51-SK21/11/201814 January 2019Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosisMultiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
86NCT03594487November 16, 201818 December 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 ControlUniversity of California, San FranciscoRecruiting18 Years60 YearsAll30Phase 1United States
87NCT03621761November 15, 20184 November 2019Cognitive 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 SocietyRecruiting18 YearsN/AAll330Phase 4United States
88NCT03691077November 11, 201818 December 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
89NCT04120675November 9, 201822 October 2019Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple SclerosisRandomized, Double Blind, Controlled Prospective Study, to Evaluate the Therapeutic Effects of Early Harvest Olive Oil in Cognitive Functions of Patients With Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis.Progressive Multiple SclerosisDietary Supplement: Freshly-Pressed Extra Virgin Olive OilAristotle University Of ThessalonikiGreek Alzheimer's Association and Related Disorders;YANNI'S OLIVE GROVERecruiting18 Years65 YearsAll150N/AGreece
90EUCTR2018-000001-23-ES06/11/20187 January 2019Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with 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 - BX-1 in spasticity due to MSSymptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol
Product Code: BX-1
Pharmaceutical Form: Oral solution
INN or Proposed INN: Dronabinol
CAS Number: 1972-08-3
Current Sponsor code: BX-1
Other descriptive name: Dronabinol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Bionorica SEAuthorisedFemale: yes
Male: yes
548Phase 3Hungary;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT03283397November 4, 201816 December 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.DMonitorCRONot recruiting18 Years55 YearsAll400Phase 3
92NCT03593590November 2, 201811 November 2019Non-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 RocheRecruiting18 YearsN/AAll1250Phase 3Austria;Belgium;Bulgaria;Colombia;Dominican Republic;Egypt;Italy;Kuwait;Montenegro;Netherlands;Panama;Paraguay;Poland;Qatar;Romania;Russian Federation;Saudi Arabia;Slovakia;Spain;Turkey;United Arab Emirates;United Kingdom;Israel
93EUCTR2018-000001-23-HU25/10/20186 November 2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with 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 - BX-1 in spasticity due to MSSymptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol
Product Code: BX-1
Pharmaceutical Form: Oral solution
INN or Proposed INN: Dronabinol
CAS Number: 1972-08-3
Current Sponsor code: BX-1
Other descriptive name: Dronabinol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Bionorica SEAuthorisedFemale: yes
Male: yes
548Phase 3Hungary
94EUCTR2017-004702-17-CZ23/10/201828 February 2019A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patientsMultiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Pharma AGAuthorised Female: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
95EUCTR2018-003231-30-ES19/10/20187 January 2019EFFECTIVENESS OF REPEATED INJECTIONS OF BOTULINUM TOXIN IN THE GAIT AND QUALITY OF LIFE OF ADULT PATIENTS WITH WEAKNESS AND MUSCLE RIGIDITY DUE TO MULTIPLE ESCLEROSISEFFECTIVENESS OF THE REPEATED INFILTRATIONS OF BOTULINUM TOXIN A IN THE GAIT AND QUALITY OF LIFE IN ADULTS WITH SPASTIC PARAPARESIA SECONDARY TO MULTIPLE SCLEROSIS - BOTULINUM TOXIN IN PATIENTS WITH SPASTIC PARAPARESIA ASSOCIATED WITH ESCLEROSIS MULTIPLEMultiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Dysport
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Current Sponsor code: Dysport
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: range
Concentration number: 250-1000
Aránzazu Vázquez DoceAuthorisedFemale: yes
Male: yes
84Phase 3Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03740295October 5, 201811 November 2019Impact 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 FoundationNot recruiting19 Years65 YearsAll60Phase 2Spain
97NCT03674099October 1, 201826 August 2019Imatinib 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;Norway;Sweden
98NCT03396822September 24, 20187 October 2019Meningeal 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.Recruiting18 Years65 YearsAll22Phase 1United States
99NCT03355365September 21, 201811 June 2019Intrathecal 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 YorkRecruiting18 Years65 YearsAll50Phase 2United States
100EUCTR2017-004702-17-EE17/09/20181 October 2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patientsMultiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
284Phase 2United States;Czech Republic;Estonia;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT03166800September 15, 201815 July 2019MitoQ for Fatigue in Multiple SclerosisMitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled TrialMultiple Sclerosis;FatigueDrug: MitoquinoneOregon Health and Science UniversityMitoQ LtdRecruiting18 Years70 YearsAll60Phase 1/Phase 2United States
102NCT03606460September 14, 201830 September 2019A 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.Not recruiting18 Years55 YearsAll140Phase 3United States
103EUCTR2017-004158-40-FR11/09/201830 April 2019NAA Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714 - INN-MSPatients with Relapsing MS or primary progressive MS
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: Ocrevus
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
Other descriptive name: ocrelizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)Authorised Female: yes
Male: yes
71Phase 3France
104EUCTR2017-004702-17-AT01/09/201819 November 2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patientsMultiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
105NCT03605238August 15, 201830 September 2019Treatment 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 HospitalNot recruiting12 Years75 YearsAll0Phase 1China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03500289August 10, 201816 September 2019Ketamine for Treatment of MS FatigueKetamine for Treatment of Multiple Sclerosis-related FatigueMultiple Sclerosis;FatigueDrug: Ketamine;Drug: MidazolamJohns Hopkins UniversityNational Multiple Sclerosis SocietyNot recruiting18 Years65 YearsAll18Phase 1/Phase 2United States
107EUCTR2017-004886-29-CZ08/08/20187 January 2019A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA 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 TRIALMultiple sclerosis (MS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
108NCT03589105August 6, 201830 September 2019A 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 RocheNot recruiting18 YearsN/AAll423Phase 4France
109NCT03584672August 5, 201823 July 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: One-leg Stance Test;Other: Functional Reach Test;Other: Four Square Step Test;Other: Timed Up an Go Test;Other: Berg Balance Scale;Other: Static Balance TestGazi UniversityNot recruiting18 YearsN/AAll30N/A
110NCT03562975July 23, 20184 November 2019Upper 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.Recruiting18 Years70 YearsAll35Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03567057July 18, 201810 September 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-5102Adamas Pharmaceuticals, Inc.Recruiting18 Years70 YearsAll540Phase 3United States
112NCT03979456July 4, 201824 June 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 InstitutetRecruiting20 Years52 YearsAll200Phase 3Sweden
113NCT03000127July 1, 201811 November 2019Testosterone for Fatigue in Men With MSA Pilot Trial of Testosterone Treatment for Fatigue in Men With Multiple SclerosisMultiple SclerosisDrug: AndroGel 1 % Topical Gel;Drug: PlacebosUniversity of California, Los AngelesWashington University School of MedicineNot recruiting18 Years60 YearsMale0Phase 2United States
114NCT03161028July 1, 201811 November 2019Lipoic Acid for Progressive Multiple Sclerosis (MS)Lipoic Acid for the Treatment of Progressive Multiple SclerosisMultiple SclerosisDrug: Lipoic acid;Drug: PlaceboVA Office of Research and DevelopmentRecruiting18 Years70 YearsAll118Phase 2United States;Canada
115EUCTR2017-004886-29-DK21/06/201819 November 2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA 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 TRIALMultiple sclerosis (MS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 300-
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 300-
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT03369665June 20, 201822 October 2019Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS)A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad®Multiple SclerosisDrug: Mavenclad®Merck KGaA, Darmstadt, GermanyNot recruiting18 YearsN/AAll486Phase 4Austria;Belgium;Czechia;Denmark;Finland;France;Greece;Hungary;Italy;Lithuania;Netherlands;Norway;Poland;Portugal;Slovakia;Spain;Sweden;United Kingdom;Germany
117NCT03423121June 19, 201826 August 2019A Trial of Bile Acid Supplementation in Patients With Multiple SclerosisA Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS PatientsProgressive Multiple SclerosisDrug: Tauroursodeoxycholic Acid;Drug: Placebo oral capsuleJohns Hopkins UniversityRecruiting18 YearsN/AAll60Phase 1/Phase 2United States
118EUCTR2017-000635-13-DE08/06/201830 April 2019Escalating therapy in steroid-refractory relapses of multiple sclerosis – comparison of methylprednisolone to immunoadsorptionEscalating therapy in steroid-refractory relapses of multiple sclerosis – comparison of methylprednisolone to immunoadsorptionMultiple Sclerosis (MS), acute episode
MedDRA version: 20.0 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2000-
Universität LeipzigAuthorised Female: yes
Male: yes
140Phase 3Germany
119NCT03493841June 8, 20181 April 2019Comparing 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 SpainNot recruiting18 YearsN/AAll20Phase 1United States
120NCT03526224June 4, 201822 October 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 BuffaloNot recruiting18 Years65 YearsAll120Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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agemax
Inclusion_
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PhaseCountries
121NCT03364036May 28, 20182 September 2019Evaluation of the Onset of Action in Highly Active Multiple Sclerosis (MS)A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple SclerosisMultiple SclerosisDrug: Mavenclad®Merck KGaA, Darmstadt, GermanyNot recruiting18 YearsN/AAll270Phase 4Australia;Austria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Poland;Spain;Sweden;United Kingdom;Belgium
122NCT03523858May 28, 201822 October 2019A 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 RocheRecruiting18 Years65 YearsAll600Phase 3United States;Algeria;Bosnia and Herzegovina;Brazil;Canada;Colombia;Costa Rica;Czechia;Denmark;Egypt;France;Guatemala;Hungary;Ireland;Italy;Lebanon;Mexico;Morocco;Netherlands;Panama;Poland;Russian Federation;Saudi Arabia;Spain;United Arab Emirates
123NCT03610139May 21, 201824 September 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 CenterRecruiting18 YearsN/AAll162N/ALebanon
124EUCTR2017-001313-93-ES11/05/201818 June 2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients 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)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTDAuthorisedFemale: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
125NCT03498131May 9, 20187 October 2019Melatonin 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 & ServicesRecruiting18 Years65 YearsAll30Early Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
126NCT03574428May 8, 20183 June 2019Single Ascending Doses Study With GNbAC1 in Healthy Male VolunteersA Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male VolunteersMultiple SclerosisDrug: GNbAC1;Other: GNbAC1 PlaceboGeNeuro Australia PTY LtdNot recruiting18 Years55 YearsMale24Phase 1Australia
127EUCTR2017-001313-93-IE03/05/20187 January 2019A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients 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)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01 (development)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01 (commercial)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
128NCT03585569May 1, 201823 July 2018Treating 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.IpsenRecruitingN/AN/AAll30Phase 3United States
129EUCTR2018-000620-34-SE24/04/20183 September 2018Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MSPatients 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]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Trade Name: Solu-Medrol
Product Name: Solu-Medrol
Pharmaceutical Form: Injection
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Department of Clinical Neuroscience, Karolinska InstitutetAuthorisedFemale: yes
Male: yes
200Phase 2Sweden
130EUCTR2017-000426-35-AT17/04/201810 September 2018The efficacy of treatment of patients with multiple sclerosis, a chronic, inflammatory, autoimmune, disease that leads to neurologic deficits and aggravates with flairs, with low doses of rituximab, an antibody directed against the CD20 epitope on B Lymphocytes, specific cells of the immune system contributing to the progression of the disease - a pilot trialEfficacy of Rituximab at low doses in Multiple Sclerosis – A prospective, randomized, double-blind, active controlled, pilo trial - Low-dose Rituximab in MSRelapse Remitting Multiple Sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: 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: Mabthera or biosimilar rituximab product
Product Name: Rituximab
Product Code: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Mabthera or biosimilar rituximab product
Product Name: Rituximab
Product Code: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Medical University of Vienna - Department of NeurologyAuthorisedFemale: yes
Male: yes
70Phase 2Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
Inclusion_
agemax
Inclusion_
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Target_
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PhaseCountries
131NCT03464448April 17, 201816 September 2019Mechanistic 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 MichiganRecruiting18 Years65 YearsAll30Phase 3United States
132NCT03501342April 9, 201822 October 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: Dynamic Balance Training;Other: Virtual reality groupGazi UniversityNot recruiting18 Years65 YearsAll39N/ATurkey
133EUCTR2017-001313-93-DK04/04/201830 April 2019A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients 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)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F. Hoffmann-La Roche LtdAuthorised Female: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
134NCT03319732April 3, 201828 January 2019A 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 LLCNot recruiting18 Years65 YearsAll323Phase 3United States
135JPRN-UMIN0000311352018/04/012 April 2019Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese PatientsNeuromyelitis OpticaMycophenolate mofetil treatment for 1 yearKobe University HospitalRecruiting20years-old80years-oldMale and Female10Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT03850301April 1, 201818 March 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 LondonRecruiting35 Years65 YearsAll44N/AUnited Kingdom
137NCT03436199March 29, 201820 August 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 SclerosisOther: Placebo;Drug: ADS-5102, 274 mg;Drug: ADS-5102, 137 mgAdamas Pharmaceuticals, Inc.Recruiting18 Years70 YearsAll540Phase 3United States
138NCT03387046March 26, 201826 August 2019A Pilot Study in Subjects 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, GermanyNot recruiting18 Years55 YearsAll7Phase 2Italy;Germany
139NCT03266965March 23, 20182 September 2019Histaminergic 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 DefenseRecruiting18 Years60 YearsAll15Phase 1United States
140EUCTR2017-004100-22-PL21/03/201828 February 2019Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple SclerosisA 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 Sclerosis (Study OS440-3004)Spasticity in patients with multiple sclerosis
MedDRA version: 20.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Arbaclofen
CAS Number: 69308-37-8
Current Sponsor code: OS440
Other descriptive name: AERT, (R)-Baclofen
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use
Osmotica Pharmaceutical US LLCNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
141EUCTR2017-004101-40-PL21/03/201828 February 2019Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005).Spasticity in patients with multiple sclerosis
MedDRA version: 20.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Arbaclofen
CAS Number: 69308-37-8
Current Sponsor code: OS440
Other descriptive name: AERT, (R)-Baclofen
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Osmotica Pharmaceutical US LLCAuthorisedFemale: yes
Male: yes
300Phase 3Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
142NCT03477500March 21, 201817 June 2019RCT 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 HospitalRecruiting18 Years50 YearsAll100Phase 3Denmark;Netherlands;Norway;Sweden
143EUCTR2017-004100-22-BG16/03/20187 January 2019Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple SclerosisA 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 Sclerosis (Study OS440-3004)Spasticity in patients with multiple sclerosis
MedDRA version: 20.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Arbaclofen
CAS Number: 69308-37-8
Current Sponsor code: OS440
Other descriptive name: AERT, (R)-Baclofen
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use
Osmotica Pharmaceutical US LLCNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
144JPRN-JapicCTI-17371115/3/201810 September 2019Efficacy 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 SclerosisIntervention name : Ofatumumab
INN of the intervention : -
Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks
Novartis Pharma K.K.Not Recruiting1855BOTH30Phase 2Japan, Russia
145NCT03249714March 15, 20184 November 2019Efficacy 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 subcutaneous injection;Drug: Placebo subcutaneous injection matching ofatumumabNovartis PharmaceuticalsNot recruiting18 Years55 YearsAll64Phase 2Japan;Russian Federation
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
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Inclusion_
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PhaseCountries
146NCT03005119March 1, 201816 December 2017Evaluation 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.Not recruiting18 Years65 YearsAll70Phase 2Israel
147EUCTR2016-004414-10-SE23/02/201812 March 2018Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily.Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily.Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Aubagio
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
MS Centrum, Department of Neurology, Sshlgrenska University HospitalAuthorisedFemale: yes
Male: yes
20Phase 4Sweden
148NCT03551275February 22, 201820 August 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-132BiocadNot recruiting18 Years60 YearsAll48Phase 1Russian Federation
149EUCTR2017-001224-22-BE02/02/201828 February 2019Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMSMultiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10067063 Term: Progressive relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: 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: Opicinumab
Product Code: BIIB033
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Opicinumab
Other descriptive name: BIIB033 (ANTI-LINGO)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Biogen Idec Research LimitedAuthorised Female: yes
Male: yes
240Phase 2United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden
150EUCTR2017-003008-30-GB31/01/201821 May 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 damage - MS-OPT Version 1.0 dated 12/10/17Multiple Sclerosis (Secondary Progressive)
MedDRA version: 20.0 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: Simvastatin 40 mg film-coated tablets
Product Name: Simvastatin 40 mg film-coated tablets
Product Code: Not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
University College LondonAuthorisedFemale: yes
Male: yes
40Phase 2United Kingdom
No.TrialIDDate_
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Last_Refreshed_
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151NCT03290131January 28, 20189 September 2019A 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 LLCNot recruiting18 Years65 YearsAll536Phase 3Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Moldova, Republic of;Poland;Serbia;United States
152NCT03399981January 24, 201824 June 2019Tysabri 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: TysabriBiogenNot recruitingN/AN/AAll72600N/AUnited States
153NCT03560739January 18, 201811 November 2019A 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 SclerosisDrug: OMB157Novartis PharmaceuticalsNot recruiting18 Years55 YearsAll284Phase 2United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain
154NCT03135249January 1, 201822 October 2019Sequential 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 CompanyNot recruiting18 Years60 YearsAll40Phase 4United States
155EUCTR2018-000516-22-PT30 April 2019Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 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 SclerosisRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TECFIDERA
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: PEGINTERFERON BETA-1A
CAS Number: 1211327-92-2
Current Sponsor code: BIIB017
Other descriptive name: PEGINTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: up to
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Biogen Idec Research LimitedNot Available Female: yes
Male: yes
340Phase 3Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT03670459December 31, 201724 September 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 UniversityNot recruiting35 Years55 YearsAll45N/AEgypt
157EUCTR2017-003328-56-GB19/12/201726 November 2018MS-STAT2 - Multiple 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 disability - MS-STAT2Multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Simvastatin 40 mg film-coated tablets
Product Name: Simvastatin 40 mg film-coated tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Simvastatine Sandoz 40 mg filmomhulde tabletten
Product Name: Simvastatine Sandoz 40 mg filmomhulde tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: SimvaHEXAL® 40 mg Filmtabletten
Product Name: SimvaHEXAL® 40 mg Filmtabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG
Product Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película
Product Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Sivatin 40 mg film-coated tablets
Product Name: Sivatin 40 mg film-coated tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten
Product Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
University College London Comprehensive Clinical Trials UnitAuthorisedFemale: yes
Male: yes
1180Phase 3United Kingdom
158NCT03385356December 19, 20171 April 2019Impact 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 MariborNot recruiting18 Years60 YearsAll89Phase 4Slovenia
159EUCTR2017-004846-31-SI14/12/20178 January 2018Vitamin D supplementation in patients with multiple sclerosisImpact of vitamin D supplementation in patients with multiple sclerosisRelapsing remitting multiple sclerosis
MedDRA version: 20.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Oleovit D3 14.400 IU/ml oral drops, solutionUniversity medical centre MariborAuthorisedFemale: yes
Male: yes
95Phase 4Slovenia
160EUCTR2017-000638-75-PL13/12/201723 July 2018UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDYMultiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10029202 Term: Nervous system disorder System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: UBLITUXIMAB
Current Sponsor code: TGTX 1101
Other descriptive name: LFB-R603
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Teriflunomide
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
TG Therapeutics, Inc.AuthorisedFemale: yes
Male: yes
440Phase 3United Kingdom;Georgia;Russian Federation;Ukraine;Poland;Spain;United States;Belarus;Serbia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT03362294December 11, 201716 September 2019Safety and Efficacy of Monthly Long-acting IM Injection of 40 mg GA Depot in Subjects With PPMSA Prospective, Multicenter, Single Arm, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)Primary Progressive Multiple SclerosisDrug: GA Depot 40mg once monthlyMapi Pharma Ltd.Recruiting18 Years65 YearsAll24Phase 2Israel
162EUCTR2017-000638-75-ES05/12/201726 March 2018UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDYMultiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10029202 Term: Nervous system disorder System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: UBLITUXIMAB
Current Sponsor code: TGTX 1101
Other descriptive name: LFB-R603
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Product Name: Teriflunomide
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
TG TherapeuticsAuthorisedFemale: yes
Male: yes
440Phase 3Serbia;Belarus;United States;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom
163EUCTR2017-000639-15-ES05/12/201726 March 2018UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDYMultiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10029202 Term: Nervous system disorder System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: UBLITUXIMAB
Current Sponsor code: TGTX 1101
Other descriptive name: LFB-R603
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Product Name: Teriflunomide
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
TG TherapeuticsAuthorisedFemale: yes
Male: yes
440Phase 3Belarus;United States;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom
164NCT02988401December 1, 201725 February 2019Intranasal 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 DefenseRecruiting18 Years70 YearsAll105Phase 1/Phase 2United States
165NCT03315923December 1, 20173 June 2019Comparison 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: Glatiramer Acetate;Drug: RituximabIsfahan University of Medical SciencesNot recruiting18 Years55 YearsAll84Phase 2/Phase 3Iran, Islamic Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT03353974December 1, 201722 October 2018Video 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 FerraraRecruiting18 Years80 YearsAll40N/AItaly
167NCT03347370November 27, 20177 October 2019A 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 GmbHNot recruiting18 YearsN/AAll626N/AGermany
168NCT03222973November 14, 201713 May 2019Efficacy 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: PlaceboBiogenNot recruiting18 Years58 YearsAll263Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom
169NCT03342638November 8, 201726 August 2019Maximizing 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 UniversityNot recruiting18 Years58 YearsAll200Phase 3United States
170EUCTR2017-001176-31-GB06/11/201728 February 2019A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studiesClinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10071068 Term: Clinically isolated syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
CAS Number: 145155-23-3
Current Sponsor code: BAY86-5046
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Bayer AG,Not Recruiting Female: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT03244696November 2, 201711 February 2019Behavior and Activity Monitoring in MSBehavior and Activity Monitoring in Multiple SclerosisRelapsing-Remitting Multiple SclerosisBehavioral: Step Tracking;Behavioral: Water TrackingOhio State UniversityNational Multiple Sclerosis SocietyRecruiting30 Years59 YearsAll200N/AUnited States
172NCT03350633November 1, 20174 November 2019Tocilizumab 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 HospitalNot recruiting18 YearsN/AAll118Phase 2/Phase 3China
173NCT02200718November 201714 March 2016A 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.Oregon Health and Science UniversityNot recruiting5 Years17 YearsBoth12Phase 1United States
174EUCTR2017-002838-23-ES27/10/201713 November 2017Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: 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: ORY2001
Product Code: ORY2001
Pharmaceutical Form: Capsule
INN or Proposed INN: Not yet requested
Current Sponsor code: ORY2001
Other descriptive name: PHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0.6-1.2
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Oryzon Genomics S. AAuthorisedFemale: yes
Male: yes
24Phase 2Spain
175NCT03368664October 24, 201728 October 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 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 CompanyRecruiting10 Years17 YearsAll50Phase 3Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT03283826October 19, 201714 October 2019Phase 1 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple SclerosisA Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisBiological: ATA188;Drug: PlaceboAtara BiotherapeuticsRecruiting18 Years65 YearsAll72Phase 1United States;Australia
177EUCTR2015-005431-41-PL16/10/201710 October 2018A late stage clinical trial to investigate the efficacy and safety of SA237 monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0 Level: LLT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SA237
Product Code: SA237-120/vial
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Satralizumab (r-INN)
CAS Number: Not known
Current Sponsor code: SA237
Other descriptive name: FULLY HUMANIZED ANTI-HUMAN IL-6 RECEPTOR (IL-6R) NEUTRALIZING MONOCLONAL ANTIBODY
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SA237
Product Code: SA237-120 PFS with NSD
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Satralizumab (r-INN)
CAS Number: Not known
Current Sponsor code: SA237
Other descriptive name: FULLY HUMANIZED ANTI-HUMAN IL-6 RECEPTOR (IL-6R) NEUTRALIZING MONOCLONAL ANTIBODY
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Chugai Pharmaceutical Co. LtdAuthorisedFemale: yes
Male: yes
90Phase 3United States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
178NCT03344094October 12, 201716 December 2017Mechanism of Action of Ocrelizumab in Multiple SclerosisMechanism of Action of Ocrelizumab in Multiple SclerosisMultiple Sclerosis;Immune System DiseasesDrug: ocrelizumabUniversity of ChicagoRecruiting18 Years65 YearsAll30N/AUnited States
179NCT03207464October 10, 201716 July 2018Molecular 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 HospitalRecruiting18 Years60 YearsAll19Phase 1/Phase 2United States
180EUCTR2017-002636-16-NL09/10/201723 October 2017Understanding problems with attention, memory and concentration in persons with multiple sclerosisCognitive impairment and functional reorganization in multiple sclerosis: The role of GABA and glutamate - GABA and glutamate in cognitive impairment in MSMultiple Sclerosis (MS). And specifically cognitive problems in MS.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: [11C]flumazenil
Pharmaceutical Form: Solution for injection in administration system
VU University medical center AmsterdamAuthorisedFemale: yes
Male: yes
Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT03185065October 4, 20171 April 2019Treatment 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 InstituteNot recruiting18 YearsN/AAll140Phase 3United States
182EUCTR2016-004719-10-ES02/10/201716 October 2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LTrelapsing multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PONESIMOD
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Product Name: Ponesimod
Product Code: ACT-128800
Actelion Pharmaceuticals Ltd.AuthorisedFemale: yes
Male: yes
800Phase 3Bulgaria;Georgia;Germany;Sweden;Croatia;Romania;Poland;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Finland;Bosnia and Herzegovina;Latvia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Portugal;United States;Belarus;Serbia
183EUCTR2017-002634-24-SE29/09/20176 November 2017MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMSNewly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
Pharmaceutical Form: Infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 500-1000
Trade Name: Tysabri
Pharmaceutical Form: Infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: Tecfidera
Pharmaceutical Form: Capsule
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Trade Name: Gilenya
Pharmaceutical Form: Tablet
INN or Proposed INN: FINGOLIMOD
CAS Number: 162359-55-9
Other descriptive name: FINGOLIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Trade Name: Copaxone
Pharmaceutical Form: Injection
INN or Proposed INN: GLATIRAMER ACETATE
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20-40
Trade Name: Betaferon
Pharmaceutical Form: Injection
INN or Proposed INN: INTERFERON BETA-1B
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Trade Name: Extavia
Pharmaceutical Form: Injection
INN or Proposed INN: INTERFERON BETA-1B
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Trade Name: Avonex
Pharmaceutical Form: Injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Trade Name: Rebif
Pharmaceutical Form: Injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Karolinska InstitutetAuthorisedFemale: yes
Male: yes
150Phase 4Sweden
184NCT03122652September 25, 201723 April 2019Randomized, 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 CompanyRecruiting18 YearsN/AAll200Phase 3France;Germany;Martinique;Switzerland;Turkey;United Kingdom;Sweden
185NCT03326505September 25, 201716 December 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 JordanRecruiting18 Years65 YearsAll60Phase 1/Phase 2Jordan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT03424733September 25, 201726 August 2019Evaluating 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
187EUCTR2017-001294-16-PL22/09/201730 April 2019A 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 FumarateRelapsing-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)
Pharmaceutical Form: Capsule
INN or Proposed INN: Not available
Current Sponsor code: RDC-5108-00, ALKS8700
Other descriptive name: Diroximel Fumarate (DRF)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 231-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Tecfidera® 120 mg
Product Name: Tecfidera® 120 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Tecfidera
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Tecfidera® 240 mg
Product Name: Tecfidera® 240 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Tecfidera
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Alkermes, Inc.Authorised Female: yes
Male: yes
420Phase 3United States;Poland;Germany
188NCT03330418September 21, 201728 January 2019A 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 mgRemeGenRecruiting18 Years65 YearsAll118Phase 3China
189EUCTR2016-003622-16-FI19/09/20172 October 2017The effect of teriflunomide on brain microglial cell activation in multiple sclerosis.Targeting SPMS: Effect of teriflunomide treatment on microglial activation in an MS patient cohort at risk of progression. A [11C]PK11195 Brain PET study.Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: AUBAGIO
Product Name: Teriflunomide
Product Code: L04AA31
Pharmaceutical Form: Film-coated tablet
Turku University HospitalAuthorisedFemale: yes
Male: yes
Phase 4Finland
190NCT03257358September 19, 20172 September 2019A 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 PharmaceuticalsNot recruiting18 YearsN/AAll370Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT03134573September 15, 20178 April 2019Medication 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: myBETAappBayerNot recruiting18 YearsN/AAll96Phase 2Germany
192NCT03282760September 9, 201728 January 2019Safety 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 StaminaliNot recruiting18 Years60 YearsAll24Phase 1Italy;Switzerland
193NCT03183869August 24, 201716 December 2017Fecal Microbial Transplantation in Relapsing Multiple Sclerosis PatientsFecal Microbial Transplantation in Relapsing Multiple Sclerosis PatientsAutoimmune Diseases;Relapsing Multiple SclerosisDrug: Fecal microbiotaLawson Health Research InstituteRecruiting18 YearsN/AAll40Phase 2Canada
194EUCTR2017-001253-13-BE23/08/201720 August 2018Does decresaed perfusion of the brain play a role in the reduced function of axons and the clinical disability and fatigue in patients with multiple sclerosis ?Does cerebral hypoperfusion play a role in reduced axonal metabolism and clinical disability in patients with multiple sclerosis ? - ROCHIMS (Role of Cerebral Hypoperfusion In Multiple Sclerosis)Patients suffering relapsing- remitting multiple sclerosis will be investigated in this study, with an EDSS score less or equal to 4.0. Patients must be older than 18 years old. There must not be any clinical evidence of an MS relpase within the 3 months prior to inclusion.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Tracleer
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
UZ BrusselAuthorisedFemale: yes
Male: yes
30Phase 2Belgium
195NCT03109288August 11, 20174 November 2019Targeting 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: Montelukast;Drug: Losartan;Drug: HydroxychloroquineNational Institute of Allergy and Infectious Diseases (NIAID)Recruiting18 Years99 YearsAll250Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT02744222August 10, 201720 August 2018Comparative 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: PlaceboBiocadNot recruiting18 Years60 YearsAll399Phase 2/Phase 3Russian Federation
197EUCTR2016-000700-29-SE07/08/201728 February 2019Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized-double blind placebo-controlled study. - SPI2Multiple 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: D-Biotin
Product Code: MD1003
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: D-BIOTIN
CAS Number: 58-85-5
Current Sponsor code: MD1003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
MEDDAY PHARMACEUTICALS SAAuthorised Female: yes
Male: yes
754Phase 3United States;Spain;Turkey;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden
198NCT03138421August 1, 20174 February 2019Central 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 TherapeuticsNot recruiting18 YearsN/AAll9Phase 1United Kingdom
199NCT03277248August 1, 201711 November 2019A 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.Not recruiting18 Years55 YearsAll500Phase 3United States
200NCT03277261August 1, 201711 November 2019A 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.Not recruiting18 Years55 YearsAll500Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT03232073July 17, 201714 October 2019Long-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 to 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: PonesimodActelionNot recruiting18 Years65 YearsAll800Phase 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
202EUCTR2016-002937-31-BE10/07/201728 February 2019A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosisRelapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
1078Phase 3Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Sweden
203NCT02903537July 6, 201711 June 2018Tolerogenic 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
204NCT03250169July 1, 201716 December 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 LondonRecruiting18 Years55 YearsAll60N/AUnited Kingdom
205EUCTR2016-002937-31-SE19/06/201728 February 2019A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosisRelapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F. Hoffmann-La Roche LtdAuthorised Female: yes
Male: yes
1078Phase 3Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT03239860June 6, 201718 December 2018Assessing 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 ServierNot recruiting18 Years55 YearsAll220Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
207NCT03381170June 1, 201711 November 2019An 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.Not recruiting18 Years55 YearsAll48Phase 2United States
208NCT02618902May 30, 201711 June 2018A 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, AntwerpRecruiting18 Years60 YearsAll9Phase 1Belgium
209NCT02901106May 23, 201721 January 2019Monitoring 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 RothschildNot recruiting18 YearsN/AAll11Phase 4France
210EUCTR2016-003587-39-SE22/05/20174 December 2018This 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
Pharmaceutical Form: Infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 500-1000
Trade Name: Tysabri
Pharmaceutical Form: Infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: Tecfidera
Pharmaceutical Form: Capsule
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Trade Name: Gilenya
Pharmaceutical Form: Tablet
INN or Proposed INN: FINGOLIMOD
CAS Number: 162359-55-9
Other descriptive name: FINGOLIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Trade Name: Copaxone
Pharmaceutical Form: Injection
INN or Proposed INN: GLATIRAMER ACETATE
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20-40
Trade Name: Betaferon
Pharmaceutical Form: Injection
INN or Proposed INN: INTERFERON BETA-1B
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Trade Name: Extavia
Pharmaceutical Form: Injection
INN or Proposed INN: INTERFERON BETA-1B
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Trade Name: Avonex
Pharmaceutical Form: Injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Trade Name: Rebif
Pharmaceutical Form: Injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Karolinska InstitutetAuthorisedFemale: yes
Male: yes
3700Phase 4Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT03126760May 22, 201718 March 2019Pilot 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: PlaceboMallinckrodtRecruiting18 YearsN/AAll66Phase 4United States
212NCT03269071May 17, 201711 March 2019Neural 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 MultiplaRecruiting18 Years55 YearsAll4Phase 1Italy
213NCT03028675May 1, 201722 October 2019pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic StresspH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic StressMultiple SclerosisDrug: Gd-DTPA-ST;Drug: ControlNYU Langone HealthNot recruiting18 Years65 YearsAll4Phase 4United States
214NCT03345940April 30, 20174 November 2019Fingolimod 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 GenovaNot recruiting18 YearsN/AAll55Phase 4Italy
215NCT03073603April 20, 201722 July 2019Discontinuation 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 BirminghamRecruiting55 YearsN/AAll250Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
216NCT02881567April 18, 20177 October 2019Efficacy 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: DaclizumabBiogenAbbVieNot recruiting18 Years55 YearsAll41Phase 3United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom
217EUCTR2016-004935-18-HU12/04/201723 October 2017A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MSMultiple Sclerosis (MS)
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not Available
CAS Number: 1393641-34-3
Current Sponsor code: GNbAC1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
GeNeuro SAAuthorisedFemale: yes
Male: yes
240Phase 2Serbia;Estonia;Czech Republic;Hungary;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy
218EUCTR2016-003100-30-ES04/04/201710 April 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: alemtuzumab
CAS Number: 216503-57-0
Current Sponsor code: GZ402673
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Genzyme CorporationAuthorisedFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
219NCT03085810April 4, 201711 November 2019Study 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 RocheNot recruiting18 Years55 YearsAll1233Phase 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
220NCT02907177March 30, 201730 September 2019Clinical 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: PlaceboActelionRecruiting18 Years55 YearsAll600Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;Russian Federation;Spain;Switzerland;United Kingdom;Croatia;Czech Republic;Norway
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
221NCT03091400March 28, 201725 June 2018Recall 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 SinaiNot recruiting21 Years60 YearsAll11Phase 2United States
222NCT03110315March 28, 201729 April 2019A 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
223NCT03093324March 15, 20172 September 2019A 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 FumarateAlkermes, Inc.Not recruiting18 Years65 YearsAll506Phase 3United States;Germany;Poland
224NCT03091569March 10, 201711 June 2018Effects 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 CreamBiogenNot recruiting18 YearsN/AAll23Phase 4Italy
225EUCTR2016-000700-29-DE08/03/201728 February 2019Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study. - SPI2Multiple 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: D-Biotin
Product Code: MD1003
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: D-BIOTIN
CAS Number: 58-85-5
Current Sponsor code: MD1003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
MEDDAY PHARMACEUTICALS SAAuthorised Female: yes
Male: yes
754Phase 3United States;Spain;Turkey;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
226NCT02975349March 7, 201728 January 2019A 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, GermanyNot recruiting18 Years65 YearsAll267Phase 2Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States
227NCT03164018March 7, 201725 February 2019Fampridine 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 & SpecialtyNot recruiting18 YearsN/AAll111Phase 2Greece
228NCT03806387March 1, 201728 January 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 YearsAll60N/ADenmark
229NCT02149706March 201714 March 2016A 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.Oregon Health and Science UniversityNot recruiting18 Years70 YearsBoth150Phase 2United States
230EUCTR2016-001448-21-SK16/02/201728 February 2019A Study of Efficacy and Safety of M2951 in 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 Multiple Sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 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: M2951
Product Code: M2951
Pharmaceutical Form: Tablet
INN or Proposed INN: M2951
Current Sponsor code: M2951
Other descriptive name: M2951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Tecfidera
Product Name: Tecfidera
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tecfidera
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Trade Name: Tecfidera
Product Name: Tecfidera
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tecfidera
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Merck KGaAAuthorised Female: yes
Male: yes
250Phase 2Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
231NCT02949908February 9, 201716 December 2017MEasuring Satisfaction of Treatment With REbif After Initial Treatment of MS (MESTRE-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: Rebif (IFNß-1b)Merck KGaAMerck B.V., NetherlandsNot recruiting18 Years65 YearsAll2N/AGermany
232NCT03193866February 1, 201729 April 2019COMparison 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 InstituteRecruiting18 YearsN/AAll3700N/ASweden
233NCT03418376February 1, 201721 January 2019Carnosine Loading 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 UniversityNot recruiting18 Years75 YearsAll45N/ABelgium
234NCT02057159February 201714 March 2016A 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.Oregon Health and Science UniversityNot recruiting18 Years50 YearsBoth200Phase 2/Phase 3United States
235NCT03021317February 201716 December 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 ChicagoNot recruiting18 YearsN/AAll18Phase 4
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
236NCT03177083January 30, 201724 September 2018Evaluate 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-1bBiogenRecruiting18 Years65 YearsAll140Phase 4Portugal
237NCT03051646January 13, 201726 November 2018Aspirin 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 SclerosisOverheating;FatigueDrug: Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit;Drug: Placebo at 1st visit, then Acetylsalicylic acid at 2nd visitColumbia UniversityNational Multiple Sclerosis SocietyNot recruiting18 Years60 YearsAll12Early Phase 1United States
238NCT03032601January 5, 201723 April 2019Physiological 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 UniversityNot recruiting30 Years80 YearsAll25N/AUnited States
239NCT03193086January 1, 201716 December 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
240NCT02481882January 201722 October 2018Baseline Cortical Haemodynamics in MSInvestigating Baseline Cortical Haemodynamics in Multiple SclerosisMultiple SclerosisDevice: Magnetic Resonance Imaging;Drug: Prohance (Gadoteridol)University of NottinghamRecruiting21 Years80 YearsAll80N/AUnited Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
241NCT02980042January 201729 April 2019Tolerability 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, DenverRecruiting18 Years65 YearsAll200Phase 3United States
242NCT03172741January 201720 August 2018The 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 UniversityNot recruiting21 Years74 YearsAll0Phase 2/Phase 3
243NCT04082260January 201730 September 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 MuensterRecruiting18 YearsN/AAll150N/AGermany
244EUCTR2017-005129-18-IT17 September 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
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Glatiramer Acetate
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Trade Name: AVONEX 30 µg/0,5 ml solution for injection
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Interferon beta-1a
CAS Number: 145258-61-3
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Università degli Studi Aldo MoroNot AvailableFemale: yes
Male: yes
142Phase 3Italy
245NCT02969304December 30, 201616 December 2017Study of Utilization Patterns of Dimethyl Fumarate in GermanyClaims Database Study of Utilization Patterns of Dimethyl Fumarate in GermanyMultiple SclerosisDrug: dimethyl fumarateBiogenNot recruitingN/AN/AAll930N/AGermany
No.TrialIDDate_
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PhaseCountries
246NCT03186664December 28, 201626 August 2019The 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-PulejoNot recruiting18 Years65 YearsAll40N/AItaly
247NCT02977533December 1, 201611 June 2018A 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: AcyclovirSanofiNot recruiting18 Years65 YearsAll20Phase 1Germany
248NCT03561402December 1, 201620 August 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 UniversityRecruiting18 Years55 YearsAll75Early Phase 1Canada
249NCT02936037December 201620 May 2019Effect 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 SANot recruiting18 Years65 YearsAll642Phase 3United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Italy;Poland;Spain;Sweden;Turkey;United Kingdom;Czech Republic;Netherlands
250NCT02959658December 20164 March 2019Dimethyl Fumarate Treatment of Primary Progressive Multiple SclerosisDimethyl Fumarate Treatment of Primary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisDrug: Dimethyl Fumarate;Drug: Placebo Oral CapsuleRigshospitalet, DenmarkBiogenNot recruiting18 Years65 YearsAll90Phase 2Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
251EUCTR2015-005431-41-HR30/11/20167 January 2019A late stage clinical trial to investigate the efficacy and safety of SA237 monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0 Level: LLT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SA237
Product Code: SA237-120/vial
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Satralizumab (r-INN)
CAS Number: Not known
Current Sponsor code: SA237
Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SA237-120 PFS with NSD
Product Code: L04AX01
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Satralizumab (r-INN)
CAS Number: Not known
Current Sponsor code: SA237
Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Chugai Pharmaceutical Co. LtdAuthorisedFemale: yes
Male: yes
90Phase 3United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
252EUCTR2016-002180-33-PL16/11/201629 January 2018Multiple sclerosis therapy with transdermal myelin peptide stimulation.Multiple sclerosis therapy with transdermal myelin peptide stimulation.relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: SMderpept
Pharmaceutical Form: Powder for cutaneous solution
INN or Proposed INN: PLP peptide
Current Sponsor code: PLP peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: MBP peptide
Current Sponsor code: MBP peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: MOG peptide
Current Sponsor code: MOG peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: SMderpept
Pharmaceutical Form: Powder for cutaneous solution
INN or Proposed INN: PLP peptide
Current Sponsor code: PLP peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: MBP peptide
Current Sponsor code: MBP peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: MOG peptide
Current Sponsor code: MOG peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Avonex
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta 1-A
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Centrum Neurologii Krzysztof SelmajAuthorisedFemale: yes
Male: yes
220Phase 2Poland
253EUCTR2012-000541-12-DE15/11/20166 November 2018Clinical 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®) - POINTRelapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Actelion Pharmaceuticals Ltd.AuthorisedFemale: yes
Male: yes
600Phase 3Greece;Finland;United States;Portugal;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Bulgaria;Germany
254EUCTR2016-000434-21-PT14/11/201630 April 2019PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)Relapsing-remitting multiple sclerosis
MedDRA version: 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: Plegridy 125 micrograms
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Peginterferon beta-1a
CAS Number: 1211327-92-2
Other descriptive name: PEGINTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 125-
Trade Name: Rebif 22 micrograms
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Interferon beta-1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Trade Name: Rebif 44 micrograms
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Interferon beta-1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Trade Name: Betaferon 250 microgram/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Trade Name: Extavia 250 micrograms/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Biogen PortugalAuthorised Female: yes
Male: yes
140Phase 4Portugal
255NCT03516526November 3, 201622 July 2019Towards 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 HospitalNot recruiting18 YearsN/AAll61Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT02913157November 201629 April 2019Hydroxychloroquine 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 CalgaryRecruiting18 Years65 YearsAll35Phase 2Canada
257EUCTR2016-001515-20-IT20/10/201612 February 2018ndEFFECT OF TERIFLUNOMIDE ON T CELL SUBPOPULATIONS IN PERIPHERAL BLOOD FROM RRMS PATIENTS - ndRELAPSING-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
Pharmaceutical Form: Film-coated tablet
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLIAuthorisedFemale: yes
Male: yes
30Phase 4Italy
258NCT02587065October 19, 201611 June 2018Plegridy 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-1aBiogenNot recruiting18 Years65 YearsAll199Phase 4Italy
259NCT02601885October 18, 201611 June 2018A 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: PlaceboAbbVieNot recruiting18 Years60 YearsAll20Phase 1United States
260NCT01649050October 201616 December 2017Efficacy 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 PharmaceuticalsNot recruiting18 Years65 YearsAll0Phase 2Germany;Russian Federation
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261NCT02807285October 201616 December 2017Expanded 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.Not recruiting18 Years55 YearsAllN/AUnited States
262EUCTR2016-000345-31-NL30/09/201610 October 2016Reduce the number of natalizumab infusions in patients with multiple sclerosisTowards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial)multiple sclerosis
MedDRA version: 18.1 Level: LLT Classification code 10070425 Term: Multiple sclerosis exacerbation System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: tysabri
Product Name: natalizumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
VU medical centerAuthorisedFemale: yes
Male: yes
60Phase 4Netherlands
263EUCTR2016-003073-18-GB29/09/20163 April 2017A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the bodyA Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).
MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration
Pharmaceutical Form: Oral solution
INN or Proposed INN: Ozanimod hydrochloride
CAS Number: 1618636-37-5
Current Sponsor code: RPC1063HCL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.1-
Celgene International II SàrlAuthorisedFemale: no
Male: yes
6Phase 1United Kingdom
264NCT03101735September 23, 201620 August 2018Study 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 & SpecialtyNot recruiting18 Years65 YearsAll455N/AGreece
265JPRN-UMIN0000243122016/09/202 April 2019Studies 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 ClinicNot Recruiting20years-old80years-oldMale and Female12Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT02792218September 20, 201616 September 2019Efficacy 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: Placebo subcutanous injection matching to ofatumumab;Drug: Teriflunomide orally;Drug: Placebo orally matching to teriflunomide;Drug: Ofatumumab subcutaneous injectionNovartis PharmaceuticalsNot recruiting18 Years55 YearsAll929Phase 3Sweden;Switzerland;Thailand;Turkey;United Kingdom;United 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
267EUCTR2015-005418-31-EE12/09/201628 February 2019Study 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 sclerosismultiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Current Sponsor code: OMB157
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Aubagio
Product Name: Teriflunomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGAuthorised Female: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
268EUCTR2016-000283-41-DK12/09/20166 November 2018Treatment with dimethyl fumarate in patients with primary progressive multiple sclerosisDimethyl fumarate treatment of primary progressive multiple sclerosis - FUMAPMSPrimary progressive multiple sclerosis (PPMS)
MedDRA version: 20.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tecfidera
Product Name: dimethyl fumarate
Product Code: dimethyl fumarate
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dimethyl fumarate
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Finn SellebjergAuthorisedFemale: yes
Male: yes
90Phase 2Denmark
269NCT02861014September 9, 201622 October 2019A 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 RocheNot recruiting18 Years55 YearsAll681Phase 3Australia;Belgium;Czechia;Denmark;Estonia;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Hong Kong
270NCT02898974September 201622 January 2018Medical 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.Not recruiting30 Years60 YearsAll19N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT02792231August 26, 201616 September 2019Efficacy 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: Placebo orally matching to teriflunomide;Drug: Teriflunomide orally;Drug: Placebo subcutaneous injection matching to ofatumumabNovartis PharmaceuticalsNot recruiting18 Years55 YearsAll900Phase 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
272EUCTR2015-003147-19-GR18/07/20168 August 2016To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS).Novel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Controlled, Add-on with Interferon Beta, Trial of Efficacy and Safety. - Efficacy and Safety study of NEUROASPIS PLP10® versus placeboRelapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NEUROASPIS PLP10®
Pharmaceutical Form: Oral liquid
INN or Proposed INN: FISH OIL,RICH IN OMEGA 3 ACIDS
Other descriptive name: FISH OIL, RICH IN OMEGA-3-ACIDS
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 42.1-
INN or Proposed INN: BORAGE OIL 20% GLA
CAS Number: 8000051-62-9
Other descriptive name: BORAGE OIL
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 43.7-
INN or Proposed INN: beta-Carotene
Other descriptive name: BETACAROTENE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.04-
INN or Proposed INN: Gamma-tocopherol
CAS Number: 54 28 4
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 4.2-
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
PALUPA Medical LtdAuthorisedFemale: yes
Male: yes
220Phase 3Greece
273NCT03436927July 15, 201626 February 2018Comparison 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 UniversityNot recruiting25 Years60 YearsAll51N/A
274NCT02660359July 8, 201611 November 2019Dysport® 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: PlaceboIpsenNot recruiting18 Years80 YearsAll258Phase 3Argentina;Australia;Belgium;Brazil;Chile;Colombia;France;Germany;Israel;Lithuania;Mexico;Peru;Russian Federation;Spain;Ukraine;United Kingdom;New Zealand
275NCT02760056July 20165 September 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 UniversityRecruiting18 Years50 YearsBoth24Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
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Target_
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PhaseCountries
276NCT02833142July 20169 January 2017Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing ProcessesA Randomized, Blinded, Parallel-Group, Phase 1 Study of Pharmacokinetics, Safety and Tolerability of Single Intravenous Doses of BIIB033 (Opicinumab ) Produced by 2 Manufacturing Processes, in Healthy VolunteersMultiple Sclerosis;Acute Optic NeuritisDrug: BIIB033 (opicinumab)BiogenNot recruiting18 Years55 YearsBoth28Phase 1United States
277NCT02869425July 20169 September 2019To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MSA Randomized, Double-Blind, Parallel-Group Study to Assess the Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With Multiple SclerosisMultiple Sclerosis;SpermDrug: arbaclofen ER Tablets;Drug: Placebo for arbaclofen ER tabletsOsmotica Pharmaceutical US LLCNot recruiting18 Years55 YearsMale0Phase 3United States
278NCT03069170July 201618 June 2018Autologous 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 ArabiaNot recruitingN/AN/AAll50Phase 1Jordan
279NCT02921035June 30, 201630 September 2019Non-interventional Study to Assess Adherence to Treatment for Patients With Relapsing Multiple SclerosisA Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With Relapsing Multiple Sclerosis (RMS) Who Are Prescribed Subcutaneous (sc) Interferon Beta-1aRelapsing Multiple SclerosisDrug: Rebif (Interferon beta-1a)Merck KGaA, Darmstadt, GermanyMerck Serono Middle East FZ LLCNot recruiting18 Years60 YearsAll594N/AAlgeria;Argentina;Bahrain;Bulgaria;Egypt;Hungary;Iran, Islamic Republic of;Korea, Republic of;Kuwait;Lebanon;Morocco;Poland;Saudi Arabia;Germany;Tunisia;United Arab Emirates
280EUCTR2015-000507-44-DE29/06/201621 May 2018A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosisA 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 caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10046543 Term: Urinary incontinence System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify
Trade Name: Dysport®
Product Name: Dysport®
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Current Sponsor code: 52120
Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intravesical use
Trade Name: Dysport®
Product Name: Dysport®
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Current Sponsor code: 52120
Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intravesical use
Ipsen InnovationAuthorisedFemale: yes
Male: yes
330Phase 3Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
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PhaseCountries
281NCT02797015June 23, 201611 June 2018Pharmacokinetics 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: RPC1063CelgeneNot recruiting18 Years55 YearsAll22Phase 1United States
282EUCTR2016-000464-42-DE13/06/201611 June 2018The 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 - LemCourseRelapsing-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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: alemtuzumab
CAS Number: 216503-57-0
Current Sponsor code: GZ402673
Other descriptive name: ALEMTUZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Genzyme GmbHAuthorisedFemale: yes
Male: yes
100Phase 3Germany
283NCT02424396June 13, 201611 February 2019Biological 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/AFMRecruiting18 Years65 YearsAll30Phase 2France
284NCT03150966June 8, 201624 September 2018The 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 SciencesNot recruiting18 Years65 YearsAll41Phase 2Iran, Islamic Republic of
285EUCTR2015-005160-41-PL07/06/201628 February 2019an 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-1Relapsing 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
Pharmaceutical Form: Capsule
INN or Proposed INN: Not available
CAS Number: Not availabl
Current Sponsor code: RDC-5108-00, ALKS 8700
Other descriptive name: ALKS 8700
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 231-
Alkermes, Inc.Authorised Female: yes
Male: yes
800Phase 3Serbia;United States;Canada;Belgium;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany
No.TrialIDDate_
enrollement
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286NCT02446886June 201614 January 2019Adrenocorticotropic 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 UniversityMallinckrodtRecruiting18 YearsN/AAll30Phase 4United States
287NCT02609607June 201618 December 2018Treating Anorectal Dysfunction in MSTreating Anorectal Dysfunction Associated With Multiple SclerosisConstipation;Fecal Incontinence;Multiple SclerosisDrug: Bisacodyl;Other: PlaceboDavid LevinthalConsortium of Multiple Sclerosis CentersNot recruiting18 Years80 YearsAll11Phase 2United States
288NCT02870023June 20164 March 2019How 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 OnlusNot recruiting18 YearsN/AAll71N/ADenmark
289NCT02784210May 26, 201623 April 2019Effect 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: MethylprednisoloneNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting25 Years55 YearsAll10Phase 2United States
290NCT02676739May 20, 20161 April 2019Adderall 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 MorrowRecruiting18 Years59 YearsAll180Phase 2/Phase 3Canada
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291EUCTR2015-005597-38-GB19/05/20167 January 2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTINGRelapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
292NCT03237832May 16, 201616 December 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 TrialsNot recruiting18 Years50 YearsAll60Phase 1
293EUCTR2015-004059-29-HU04/05/201619 February 2018Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MSMultiple Sclerosis (MS)
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: GNbAC1
Product Code: GNbAC1
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not available
CAS Number: 1393641-34-3
Current Sponsor code: GNbAC1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: GNbAC1
Product Code: GNbAC1
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not available
CAS Number: 1393641-34-3
Current Sponsor code: GNBAC1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: GNbAC1
Product Code: GNbAC1
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not available
CAS Number: 1393641-34-3
Current Sponsor code: GNBAC1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
GeNeuro SANot RecruitingFemale: yes
Male: yes
260Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Czech Republic;Poland;Croatia;Bulgaria;Germany
294NCT02749396May 2, 201626 August 2019EPID Multiple Sclerosis Pregnancy StudyPregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon ß - a Register-based Study in the Nordic CountriesMultiple SclerosisDrug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG;Drug: Extavia (interferon beta-1b), Novartis Pharma AG;Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd;Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd;Drug: Avonex (interferon beta-1a), Biogen Idec Ltd;Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046);Other: No MSDMDs therapy (control)BayerEPID Research;Biogen;Merck Serono Europe Ltd;Novartis PharmaceuticalsNot recruitingN/AN/AFemale2089Early Phase 1Finland
295NCT03566251May 1, 20162 July 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 UniversityNot recruiting18 Years65 YearsAll74N/ATurkey
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296NCT02428218May 201625 April 2016Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Relapsing Forms of Multiple SclerosisDrug: Placebo;Drug: dimethyl fumarateBiogenNot recruiting10 Years17 YearsBoth0Phase 3
297NCT02670161May 201626 August 2019Quality 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 HealthSystemRecruiting18 Years100 YearsAll3300Phase 4
298NCT02746744May 201617 June 2019RItuximab 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 SvenningssonNot recruiting18 Years50 YearsAll200Phase 3Sweden
299NCT02688985April 29, 201611 November 2019Study 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.Recruiting18 Years55 YearsAll120Phase 3United States;Canada;Germany;Sweden
300NCT02675413April 20168 August 2016Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MSMechanisms of Action of Dimethyl Fumarate in Relapsing MSMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Dimethyl FumarateWashington University School of MedicineBiogenNot recruiting18 YearsN/ABoth0Phase 4United States
No.TrialIDDate_
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301NCT02769689April 201623 May 2016Methylprednisolone During the Switch Between Natalizumab and FingolimodOnce a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY)Multiple SclerosisDrug: Methylprednisolone;Drug: Placebo;Drug: natalizumab (NTZ);Drug: fingolimob (FTY)University Hospital, Clermont-FerrandRecruiting18 Years65 YearsBoth56Phase 4France
302NCT02739542March 19, 201627 May 2019Assessment 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 CenterBiogenRecruiting18 YearsN/AAll90Phase 4United States
303NCT02738775March 18, 201611 November 2019Phase 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.Not recruiting18 Years55 YearsAll48Phase 2United States
304NCT02636829March 201626 September 2016Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory ArthritisValidation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory ArthritisMultiple Sclerosis;Rheumatoid ArthritisOther: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interviewCentre Hospitalier Universitaire de NimesNot recruiting18 Years69 YearsBoth100N/AFrance
305NCT02660138March 201611 November 2019Dysport® 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: PlaceboIpsenNot recruiting18 Years80 YearsAll227Phase 3United States;Canada;Czechia;Italy;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Turkey;Czech Republic;Malaysia
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306NCT02555215February 22, 201618 December 2018Extension 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 fumarateBiogenNot recruiting10 Years17 YearsAll20Phase 3United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic
307EUCTR2015-004451-40-CZ17/02/20163 July 2017SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSSATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICS THE S A V A N T TRIAL - SAVANTModerate 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
Pharmaceutical Form: Oromucosal spray
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Oromucosal use
Almirall Hermal GmbHNot RecruitingFemale: yes
Male: yes
228Phase 4Czech Republic;Austria
308NCT02575365February 16, 201616 December 2017Effect 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 PharmaceuticalsNot recruiting18 Years65 YearsAll4Phase 4Turkey
309NCT02637856February 11, 201630 September 2019A 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.Not recruiting18 Years55 YearsAll611Phase 3United States;Canada
310NCT02652091February 5, 201617 September 2018Impact 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 deviceBayerNot recruiting18 YearsN/AAll146Phase 1United States
No.TrialIDDate_
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311EUCTR2015-002820-20-NL03/02/20167 January 2019Are 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 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: Silodyx
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Erasmus MC Dept. UrologyAuthorisedFemale: yes
Male: no
30Phase 3Netherlands
312NCT02601131February 201612 December 2016Post-transfusion Platelet CountPost-transfusion Platelet CountLeukemia;Multiple SclerosisBiological: Platelet transfusionRegion SkaneNot recruiting18 YearsN/ABoth80N/ASweden
313NCT02641041February 201617 October 2016Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese ParticipantsA Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese SubjectsCentral Nervous System (CNS) Demyelinating Disease;Multiple SclerosisBiological: BIIB033;Other: PlaceboBiogenNot recruiting20 Years55 YearsBoth24Phase 1United Kingdom
314NCT02644083February 201610 September 2018Tecfidera 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 UniversityBiogenNot recruiting18 Years55 YearsAll4N/AUnited States
315NCT02710214February 201615 July 2019A TSEC for Symptom Management in Menopausal Women With Multiple SclerosisEffect of a Tissue Selective Estrogen Complex on Menopausal Symptoms in Women With MS: A Pilot Trial.Menopause;Multiple SclerosisDrug: Tissue Selective Estrogen Complex;Drug: PlaceboUniversity of California, San FranciscoNational Multiple Sclerosis SocietyNot recruiting18 Years62 YearsFemale24Phase 2United States
No.TrialIDDate_
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316NCT02823951February 201612 March 2018Patient 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 SeronoNot recruiting18 Years55 YearsAll479N/AUnited States;Canada
317JPRN-UMIN0000222012016/01/102 April 2019The efficacy and safety of tocilizumab in patients with neuromyelitis opticaneuromyelitis opticaTocilizumab it to be infused every 4weeks at 8mg/kg of body weight for 2 years.Department of Neurology, Shimane University HospitalRecruiting20years-old74years-oldMale and Female3Not selectedJapan
318ChiCTR-OPB-160077302016-01-0118 April 2017Mycophenolate Mofetil Treatment of Neuromyelitis Optica in Chinese Patients (MONICA)Mycophenolate Mofetil Treatment of Neuromyelitis Optica in Chinese Patients (MONICA)Neuromyelitis opticaCase series:Mycophenolate Mofetil;The third affiliated hospital,Sun Yat-sen universityRecruiting1865BothCase series:100;Post-marketChina
319NCT02276963January 201617 June 2019Ublituximab 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 UniversityNot recruiting18 Years100 YearsAll6Phase 1United States
320NCT02644044January 201618 January 2016Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm StudyIntrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm StudyTo Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MSDrug: Intrathecal methotrexateTel-Aviv Sourasky Medical CenterNot recruiting18 Years75 YearsBoth30Phase 0
No.TrialIDDate_
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321NCT02649985January 201611 June 2018Microglial 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]PBR06Brigham and Women's HospitalRecruiting18 Years70 YearsAll50Phase 1/Phase 2United States
322NCT02809079January 201627 June 2016Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese PatientsMycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese PatientsNeuromyelitis Optica Spectrum Disorders;Mycophenolate Mofetil;Efficacy and SafetyDrug: Mycophenolate mofetil;Drug: PrednisoneThird Affiliated Hospital, Sun Yat-Sen UniversityZhongshan Ophthalmic Centre, Sun Yat-sen University;Nangfang Hospital, Southern Medical UniversityRecruiting18 Years65 YearsBoth100Phase 4
323EUCTR2016-003100-30-BG28 February 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)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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: alemtuzumab
CAS Number: 216503-57-0
Current Sponsor code: GZ402673
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Genzyme CorporationNot Available Female: yes
Male: yes
65Phase 3Norway;Netherlands;Germany;Bulgaria;Poland;Belgium;France;Italy;United Kingdom;Switzerland;Russian Federation;Austria;Turkey;Spain;Greece;Portugal
324NCT02677077December 31, 201514 January 2019Clinical Disease Activity With Long Term Natalizumab TreatmentMRI and Clinical Disease Activity in Patients Treated Long Term With NatalizumabRelapsing-Remitting Multiple SclerosisDrug: natalizumabBiogenNot recruiting18 Years65 YearsAll277Phase 2Belgium;Czechia;Czech Republic
325EUCTR2015-004116-38-SE18/12/201522 January 2018A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis.RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MS A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis Objective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design. Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion. Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months. Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion. Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed.Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
Pharmaceutical Form: Infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 500-1000
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Trade Name: Tecfidera
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 480-
Department of Clinical Sciences, Danderyd HospitalAuthorisedFemale: yes
Male: yes
200Phase 3Sweden
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326NCT02587195December 18, 201511 June 2018A 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 NiceNot recruiting18 Years55 YearsAll5Phase 3France
327NCT02583594December 6, 20155 November 2018A 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 CompanyNot recruiting18 YearsN/AAll24Phase 1Spain
328NCT02011451December 20153 October 2016Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple SclerosisSafety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple SclerosisMultiple SclerosisDrug: 95% Pure ECGC capsules 200mg;Drug: Placebo Comparator:Louisiana State University Health Sciences Center in New OrleansNational Multiple Sclerosis SocietyNot recruiting18 Years65 YearsBoth0Phase 2United States
329NCT02634307December 201514 October 2019A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1A 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 8700Alkermes, Inc.Not recruiting18 Years65 YearsAll1057Phase 3United States;Belgium;Bulgaria;Germany;Poland;Russian Federation;Serbia;Spain;Ukraine
330NCT02471560November 30, 201512 February 2018Tecfidera 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 DMTBiogenNot recruiting18 YearsN/AAll37Phase 4Norway
No.TrialIDDate_
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Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT02545959November 30, 201514 October 2019Intrathecal 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, BordeauxNot recruiting45 YearsN/AAll10Phase 2France
332JPRN-JapicCTI-15305824/11/201516 July 2019Copaxone 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 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.RecruitingBOTH1000NA
333NCT02633033November 24, 20154 February 2019Observational Registry of H.P. Acthar® Gel for Multiple Sclerosis RelapseA Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis RelapseMultiple Sclerosis, Relapsing-RemittingDrug: H.P. Acthar® Gel (repository corticotropin injection)MallinckrodtNot recruiting18 YearsN/AAll160Phase 3United States;Puerto Rico
334EUCTR2012-003735-32-GR19/11/201523 July 2018Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatmentRelapsing-remitting multiple sclerosis (RR MS)
MedDRA version: 18.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: mastinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: masitinib mesylate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: mastinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinb mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: masitinib mesylate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
AB ScienceNot RecruitingFemale: yes
Male: yes
450Phase 3Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany
335EUCTR2015-002500-91-BE10/11/201528 February 2019A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) studyRelapsing Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Product Name: 1.0mg RPC1063
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Celgene International II Sàrl (CIS II)Authorised Female: yes
Male: yes
2496Phase 3Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT02490982November 201516 December 2017Teriflunomide 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 HospitalRecruiting18 YearsN/AAll300N/ACanada
337NCT02686684November 20157 November 2016Tecfidera Diffusion Tensor ImagingAn Open-label, Observational, Single-blinded, Longitudinal Study to Evaluate the Effect of Dimethyl Fumarate on Gray and White Matter Pathology in Subjects With Relapsing Multiple SclerosisMultiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance ImagingDrug: Dimethyl fumarateUniversity at BuffaloNot recruiting18 YearsN/ABoth115N/A
338NCT02743312November 201524 October 2016Long-Term Effects of Torso-WeightingLong-Term Effects of Balance-Based Torso-Weighting: Pilot StudyMultiple SclerosisDevice: Balance-Based Torso-Weighting (WT);Device: Sham Weights (SW);Device: Fitbit FlexSan Francisco State UniversitySamuel Merritt University;Samuel Merritt UniversityNot recruiting18 YearsN/ABoth5N/AUnited States
339NCT02545868October 27, 201511 November 2019A 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 RocheNot recruiting18 Years55 YearsAll102Phase 3United States;Canada
340EUCTR2015-002500-91-HU12/10/201528 February 2019A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) studyRelapsing Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Product Name: 1.0mg RPC1063
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Celgene International II Sàrl (CIS II)Authorised Female: yes
Male: yes
2496Phase 3Belgium;Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341NCT02529839October 201531 August 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 OrganizationNot recruiting18 Years65 YearsBoth20N/A
342NCT02606630October 201516 December 2017[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-555AbbVieNot recruiting18 Years60 YearsAll4Phase 1United Kingdom
343EUCTR2012-000540-10-DE23/09/201525 June 2018International clinical trial to compare ponesimod and 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 sclerosis - OPTIMUMrelapsing multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Capsule
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
CAS Number: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Aubagio®
Product Name: Aubagio®
Pharmaceutical Form: Tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
CAS Number: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
CAS Number: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
CAS Number: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ponesimod
Actelion Pharmaceuticals LtdAuthorisedFemale: yes
Male: yes
1100Phase 3Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
344EUCTR2014-003498-41-AT22/09/201528 September 2015Effects of dalfampridine on mobility in the context of daily lifeEffects of dalfampridine on mobility in the context of daily life - Fampridine Study in Activities of Daily LivingMotor behaviour and cognition in multiple sclerosis patients;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Fampyra
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Medical University of ViennaAuthorisedFemale: yes
Male: yes
Austria
345NCT02486640September 8, 201511 November 2019Evaluation 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 AutoinjectorBayerNot recruiting18 YearsN/AAll162N/AGermany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346NCT03774914September 1, 201526 August 2019LEMTRADA Pregnancy Registry in Multiple SclerosisInternational LEMTRADA Pregnancy Exposure Cohort in Multiple SclerosisMultiple SclerosisDrug: Alemtuzumab (GZ402673)Genzyme, a Sanofi CompanyRecruiting18 Years55 YearsFemale204Phase 2United States;Austria;Belgium;Canada;Denmark;Germany;Italy;Spain;Sweden;United Kingdom
347NCT02283671September 201525 February 2019Treatment 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 VareaRecruiting18 Years65 YearsAll22Phase 1Spain
348NCT03002038September 20159 January 2017Comparison 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 SciencesNot recruiting18 Years50 YearsBoth76Phase 2/Phase 3Iran, Islamic Republic of
349NCT02499900August 31, 201516 December 2017Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL DailyMultiple SclerosisDrug: Copaxone®Teva Pharmaceutical Industries, Ltd.Not recruiting18 YearsN/AAll861Phase 4United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey
350NCT02525874August 31, 20153 December 2018Effect 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 fumarateBiogenNot recruiting18 Years65 YearsAll218Phase 3United States;Belgium;Bulgaria;Kuwait;Lithuania;Poland;Turkey;Croatia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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gender
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size
PhaseCountries
351EUCTR2014-000395-26-DE07/08/201530 October 2017Description ofchanges in that part of the nervous sstem that is processing visual information over an extended perion of time in patients with relapsing remitting multiple sclerosis who take TecfideraA 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate - VISIONRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tecfidera
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dimethyl fumarate
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Biogen GmbHNot RecruitingFemale: yes
Male: yes
600Phase 4Germany
352NCT01532154August 201531 October 2016Fampridine Pregnancy Exposure RegistryFampridine Pregnancy Exposure RegistryMultiple Sclerosis;PregnancyDrug: FampridineBiogenNot recruitingN/AN/AFemale1N/AFrance;Germany;United Kingdom;United States
353NCT02493049August 201522 October 2019Pilot 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 SolutionsNot recruiting18 Years60 YearsAll17Phase 2Canada
354NCT02542787August 201512 March 2018Study 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 LtdNot recruiting18 Years70 YearsAll160Phase 2United Kingdom
355NCT02632591August 201528 December 2015Use on Human Beings of Mix of Known Drugs for New Destination - MS TreatmentUse on Human Being of a Mix Between Very Well Known Drugs, Tested Upon Registered Trial n° NCT02606929, to Consider Effectiveness of Improvement After 45 DaysMultiple Sclerosis;Autoimmune Disease;Disseminated or Multiple Sclerosis Nos;Multiple Sclerosis, Acute Relapsing;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic ProgressiveDrug: Tetracycline;Drug: statin;Drug: antimycotic;Drug: Fingolimod;Drug: copaxoneUniversità Popolare Homo & NaturaNot recruiting18 Years65 YearsBoth90Phase 1Italy
No.TrialIDDate_
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PhaseCountries
356NCT02683863August 201516 December 2017Pharmacokinetics 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 YorkBiogenNot recruiting25 Years65 YearsAll20Phase 4United States
357NCT02686788August 20153 December 2018TMP001 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 GmbHNot recruiting18 Years55 YearsAll9Phase 2Germany
358NCT03046251August 201526 August 2019Natalizumab in Preventing Post-partum Relapses in Multiple SclerosisNatalizumab in Preventing Post-partum Relapses in Multiple SclerosisMultiple SclerosisDrug: NatalizumabState University of New York at BuffaloRecruiting18 YearsN/AFemale100Phase 4United States
359NCT02511028July 28, 20151 April 2019In 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 SclerosisOther: FerumoxytolNational Institutes of Health Clinical Center (CC)National Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years70 YearsAll14Early Phase 1United States
360EUCTR2014-004483-38-DE16/07/20157 May 2018TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trialTMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trialPatients with defined diagnosis of relapsing-remitting multiple sclerosis and at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years.
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: Tarenflurbil
Product Code: TMP001
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tarenflurbil
CAS Number: 5104-49-4
Other descriptive name: FLURBIPROFEN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME)Not RecruitingFemale: yes
Male: yes
55Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
361JPRN-UMIN0000181542015/07/012 April 201911C-acetate PET for Multiple sclerosis11C-acetate PET for Multiple sclerosis - 11C-acetate PET for Multiple sclerosisMultiple Sclerosis, NMOWithdraw blood before and after the injection of 11C-acetatedepartment of neurology, Osaka university school of medicineRecruiting20years-old75years-oldMale and Female30Not applicableJapan
362NCT02472938July 20154 January 2016Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple SclerosisPhase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: dimethyl fumarate;Other: PlaceboBiogenGB Pharma Services & Consulting S.r.l. UnipersonaleNot recruiting18 Years50 YearsBoth0Phase 4
363NCT02506751July 201519 February 2018Open-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 UniversityNot recruiting18 Years58 YearsAll20Phase 1United States
364NCT02519413July 20155 September 2016Tecfidera Lymphocyte Chart ReviewA Retrospective, Multi-Center, Observational Study to Assess the Effect of Tecfidera® Delayed-Release Capsules on Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis (REALIZE)Multiple SclerosisDrug: dimethyl fumarateBiogenNot recruiting18 YearsN/ABoth483N/AUnited States
365NCT02521545July 201514 September 2015Single-Dose Study of a New Formulation of BIIB061A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061Multiple SclerosisDrug: BIIB061BiogenNot recruiting20 Years55 YearsBoth8Phase 1United States
No.TrialIDDate_
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PhaseCountries
366NCT02665221July 201516 December 2017Single 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 MedicineNot recruiting18 Years70 YearsAll32Phase 4United States
367NCT02696590July 201511 April 2016High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis PatientsIsfahan University of Medical SciencesRelapsing Remitting Multiple SclerosisDietary Supplement: Vitamin D3Isfahan University of Medical SciencesNot recruiting23 Years59 YearsBoth200N/AIran, Islamic Republic of
368NCT02410278June 29, 201511 June 2018Study 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: PlaceboBiogenNot recruiting18 YearsN/AAll63Phase 4United States
369EUCTR2015-000303-21-IT24/06/201511 April 2016Experimental clinical trial regarding relapsing-remitTing Multiple Sclerosis newly diagnosed patients, not yet treated for the evaluation of the onset, the efficacy and speed of action of the treatment with BG00012A Phase IV, interventional, multicenteR, double-blind, randomized, placebo-controlled study tO explore the onset of efficacy on Magnetic resonance disease activity of BG00012 (dimethyl fumarate) in Patients with relapsing-remitTing Multiple Sclerosis (PROMPT) - PROMPTRelapsing-remitting Multiple Sclerosis patients
MedDRA version: 17.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tecfidera®
Product Name: Tecfidera®
Product Code: BG00012
Pharmaceutical Form: Capsule
INN or Proposed INN: Dimethyl fumarate
CAS Number: 624-49-7
Current Sponsor code: BG00012
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Biogen Idec Italia S.r.l.Not RecruitingFemale: yes
Male: yes
Phase 4Italy
370EUCTR2014-004562-22-BE10/06/201530 April 2018Study to evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple SclerosisA 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 Sclerosis
MedDRA version: 17.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Germany;Italy
No.TrialIDDate_
enrollement
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371NCT02425644June 4, 201516 September 2019Oral 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: teriflunomideActelionNot recruiting18 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
372EUCTR2014-005003-24-LV01/06/201524 October 2016A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis'Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 YearsRelapsing-Remitting Multiple Sclerosis
MedDRA version: 17.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
20Phase 2Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Latvia;Germany;Kuwait
373NCT02090348June 201514 September 2015Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl FumarateA Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)Relapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: dimethyl fumarateBiogenNot recruiting18 YearsN/ABoth0Phase 4
374NCT02239393June 20151 April 2019Safety 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 InstituteNot recruiting18 Years50 YearsAll40Phase 2Canada
375NCT03113162May 29, 201516 December 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 CenterRecruiting18 Years60 YearsAll15Phase 1Philippines
No.TrialIDDate_
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376EUCTR2013-001055-12-IT28/05/201510 July 2015Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß.Flu-like syndrome Inhibition Giving anti-histaminic Therapy. Randomized cross-over, single-center, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine on Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. - FLU-LIGHTPatients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneß, suffering from flu-like syndrome (FLS).
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: Cetirizina Mylan Generics
Product Name: Cetirizina Mylan Generics
Pharmaceutical Form: Tablet
INN or Proposed INN: Cetirizina
CAS Number: 83881-52-1
Other descriptive name: CETIRIZINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Biogen Idec Italia S.r.l.Not RecruitingFemale: yes
Male: yes
Italy
377NCT02315872May 22, 20159 September 2019ACTH 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 & ServicesMallinckrodtNot recruiting18 Years65 YearsAll8Phase 3United States
378EUCTR2015-001197-18-NO20/05/201525 June 2018The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events.The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events.multiple sclerosis;Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]Trade Name: Tecfidera
Product Name: Tecfidera
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: range
Concentration number: 240-480
Biogen Idec NorwayAuthorisedFemale: yes
Male: yes
70Phase 4Norway
379EUCTR2014-003481-25-DE13/05/201520 August 2018Investigation 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-MSrelapsing remitting multiple sclerosis
MedDRA version: 19.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tecfidera® 120mg magensaftresistente Hartkapseln
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Dimethyl fumarate
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Trade Name: Tecfidera® 240mg magensaftresistente Hartkapseln
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Dimethyl fumarate
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Universitätsklinikum MünsterNot RecruitingFemale: yes
Male: yes
67Phase 4Germany
380NCT02495766May 11, 201522 July 2019Autologous 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)Not recruiting18 Years60 YearsAll8Phase 1/Phase 2Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
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381NCT02461069May 6, 201522 October 2018Investigation 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 MuensterBiogenNot recruiting18 Years60 YearsAll67Phase 4Germany
382NCT02323269May 201518 April 2016Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple SclerosisDrug: dimethyl fumarateBiogenNot recruiting18 YearsN/ABoth24N/ACanada
383NCT02419378May 201527 June 2016Alemtuzumab 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 CompanyRecruiting18 Years55 YearsBoth15Phase 4Germany
384NCT02419638May 201514 March 2016Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MSMultiple SclerosisDrug: Rebif (IFN ß-1a subcutaneous three times per week);Drug: Tecifdera (dimethyl fumarate)Brigham and Women's HospitalEMD SeronoNot recruiting18 Years65 YearsBoth0N/AUnited States
385NCT02471222May 201516 December 2017Safety 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.Not recruiting18 Years70 YearsAll60Phase 2United States
No.TrialIDDate_
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Last_Refreshed_
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386NCT02736279May 201514 November 2016Impact of Tecfidera on Gut MicrobiotaMeasuring the Impact of Tecfidera on the Gut Microbiota: Does a Change in the Gut Flora Correlate With Gastrointestinal Disturbances Following Therapy Initiation?Multiple SclerosisDrug: Dimethyl fumarateVirginia SimnadBiogenRecruiting18 YearsN/ABoth25N/AUnited States
387EUCTR2014-005548-17-FR28/04/20153 April 2017TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR: A CONTROLED OPEN-LABEL STUDYTREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR: A CONTROLED OPEN-LABEL STUDYPENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR
MedDRA version: 18.0 Level: PT Classification code 10029864 Term: Nystagmus System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: NEURONTIN
Product Name: Gabapentine
Product Code: N03AX12
Pharmaceutical Form: Capsule
CAS Number: 60142-96-3
Other descriptive name: GABAPENTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: EBIXA
Product Name: MEMANTINE
Product Code: N06DX01
Pharmaceutical Form: Coated tablet
INN or Proposed INN: MEMANTINE
CAS Number: 19982-08-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
HOSPICES CIVILS DE LYONNot RecruitingFemale: yes
Male: yes
Phase 2France
388JPRN-UMIN0000172172015/04/2123 April 2019An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis opticaAn open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2Neuromyelitis opticaRituximab intravenous infusionClinical Research Center, Utano National Hospital, National Hospital OrganizationZenyaku Kogyo Co., Ltd.Not Recruiting16years-old80years-oldMale and Female40Phase 2,3Japan
389NCT02423083April 21, 201511 November 2019Oral 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)Not recruiting18 Years55 YearsAll2Phase 1United States
390EUCTR2014-002592-29-CZ17/04/201517 May 2016Administration of Mirabegron 50mg in patients with neurogenic bladderA randomized, double blind, placebo controlled study to evaluate the efficacy and safety of mirabegron 50 mg versus placebo in patients with neurogenic detrusor overactivity - MIRAGESpinal cord injury Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Betmiga
Product Name: Betmiga
Pharmaceutical Form: Coated tablet
INN or Proposed INN: mirabegron
CAS Number: 223673-61-8
Other descriptive name: MIRABEGRON
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Fakultní nemocnice OstravaAuthorisedFemale: yes
Male: yes
Phase 3Czech Republic
No.TrialIDDate_
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391EUCTR2012-003735-32-SK01/04/201512 November 2018Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatmentProspective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: mastinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: masitinib mesylate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: mastinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: masitinib mesylate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
AB ScienceNot RecruitingFemale: yes
Male: yes
450Phase 3Slovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany
392NCT02391961April 1, 201529 April 2019Study 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 DevelopmentNot recruiting18 Years65 YearsAll20Phase 2United States
393NCT02398461April 20153 September 2018An 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 SciencesNot recruiting18 Years70 YearsAll27Phase 1United States
394NCT02939079April 201531 October 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 SciencesNot recruiting18 Years45 YearsBoth50Phase 2/Phase 3
395NCT02373098March 31, 201516 December 2017Fingolimod 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 PharmaceuticalsNot recruiting18 Years65 YearsAll66Phase 4Turkey
No.TrialIDDate_
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396EUCTR2014-003021-18-SE25/03/20157 December 2015A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis
MedDRA version: 17.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Dimethyl Fumarate
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: Dimethyl Fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
1170Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden
397NCT02386566March 20, 201524 September 2018Observational 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: natalizumabBiogenNot recruiting18 Years65 YearsAll48Phase 1Switzerland
398EUCTR2014-003145-99-GB19/03/201517 August 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 OneRelapsing-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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Bexarotene
CAS Number: 153559-49-0
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: range
Concentration number: 100-300
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Cambridge University Hospitals NHS Foundation Trust and the University of CambridgeAuthorisedFemale: yes
Male: yes
50Phase 2aUnited Kingdom
399NCT02474134March 201523 November 2015Comparison Study of PF530 and Betaferon in Healthy SubjectsA Phase 1 Double-Blind, Randomised, Two-Treatment Cross-over Study Comparing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF530 and Betaferon Administered by Subcutaneous Injection in Healthy Adult VolunteersMultiple SclerosisDrug: Interferon beta-1b (PF530, Betaferon)Pfenex, IncNot recruiting18 Years50 YearsBoth12Phase 1Australia
400NCT02097849February 28, 201516 December 2017Vaccination 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 interferonBiogenNot recruiting18 Years55 YearsAll71Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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401NCT02343159February 28, 201516 December 2017Study 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 counselingBiogenNot recruiting18 Years65 YearsAll84Phase 4United States
402EUCTR2015-000182-31-NL11/02/201523 February 2015Study to evaluate the effects of fampridine in patients with multiple sclerosis and eye movement abnormalityA randomized, double-blind, placebo-controlled, cross-over study to assess the effects of fampridine on eye movements and nerve conduction in patients with multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO)Multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Fampyra 10 mg prolonged-release tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
CHDRAuthorisedFemale: yes
Male: yes
Netherlands
403EUCTR2014-001643-20-DE10/02/201513 February 2017Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple SclerosisA Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS)Nervous System Diseases
MedDRA version: 18.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR339658
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Vatelizumab
CAS Number: 1238217-55-4
Current Sponsor code: SAR339658
Other descriptive name: CHR-1103 / GBR500
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Vatelizumab
CAS Number: 1238217-55-4
Current Sponsor code: SAR339658
Other descriptive name: CHR-1103 / GBR500
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Vatelizumab
CAS Number: 1238217-55-4
Current Sponsor code: SAR339658
Other descriptive name: CHR-1103 / GBR500
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Genzyme CorporationNot RecruitingFemale: yes
Male: yes
168Phase 2United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden
404EUCTR2013-003884-71-BE05/02/201510 July 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) - TOPAZRelapsing-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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: alemtuzumab
CAS Number: 216503-57-0
Current Sponsor code: GZ402673
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Genzyme CorporationAuthorisedFemale: yes
Male: yes
799Phase 3BSerbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
405NCT02306811February 20159 January 2017Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839Relapsing-remitting Multiple SclerosisDrug: VatelizumabGenzyme, a Sanofi CompanyNot recruiting18 YearsN/ABoth62Phase 2United States;Canada;Poland;Russian Federation
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PhaseCountries
406NCT02308137February 201529 April 2019Domperidone 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 SolutionsRecruiting18 Years60 YearsAll62Phase 2Canada
407NCT02403947February 201510 December 2018MEsenchymal StEm Cells for Multiple SclerosisTreatment of Multiple Sclerosis With Mesenchymal Stem Cells: Phase I/II StudyMultiple SclerosisDrug: Mesenchymal stem cells;Drug: Suspension mediaUniversity Hospital, ToulouseNot recruiting18 Years50 YearsAll1Phase 1/Phase 2France
408NCT02418325February 201517 November 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 LimitedNot recruiting18 Years60 YearsBoth69Phase 1/Phase 2Trinidad and Tobago
409NCT02418351February 201517 November 2015A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMSAn Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMSMultiple Sclerosis, Relapsing-RemittingBiological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapyGenesis LimitedNot recruiting18 Years60 YearsBoth69Phase 1/Phase 2India;Trinidad and Tobago
410NCT02490046February 20153 August 2015D-mannose for the Prevention of UTIs in Multiple SclerosisSingle Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple SclerosisMultiple Sclerosis;Recurrent Urinary Tract InfectionsDietary Supplement: D MannoseUniversity College, LondonUCLHRecruiting18 Years65 YearsBoth20Phase 1United Kingdom
No.TrialIDDate_
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411NCT02587715February 201517 November 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 LLPRecruiting18 Years60 YearsBoth69Phase 1/Phase 2Trinidad and Tobago
412NCT02587806February 201517 November 2015A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMSAn Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMSMultiple Sclerosis, Relapsing-RemittingBiological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapyNovo Cellular Medicine Institute LLPRecruiting18 Years60 YearsBoth69Phase 1/Phase 2India;Trinidad and Tobago
413NCT02638038February 201512 March 2018This 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.Not recruiting18 Years50 YearsAll228Phase 2
414NCT03092544February 201511 June 2018Investigating 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;BiogenNot recruiting18 Years65 YearsAll57Phase 4United States
415EUCTR2013-005586-39-DE29/01/201516 November 2015Natalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) 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)Multiple Sclerosis (MS)
MedDRA version: 17.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri®
Product Name: AN100226, BG00002
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 300-
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
200Phase 4United States;Germany;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
416NCT02166021January 29, 201526 August 2019Clinical 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 KarussisNot recruiting18 Years65 YearsAll48Phase 2Israel
417EUCTR2014-005129-10-FI27/01/20152 February 2015Multiple Sclerosis, menopause and hormone replacement therapyMultiple Sclerosis and Menopause: the effect of hormone replacement therapy on clinical picture and immunology of multiple sclerosisMultiple sclerosis
MedDRA version: 17.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis System Organ Class: 100000004852
MedDRA version: 17.1 Level: LLT Classification code 10070425 Term: Multiple sclerosis exacerbation System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Femoston 2/10
Product Name: Femoston 2/10
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
CAS Number: 35380-71-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
INN or Proposed INN: DYDROGESTERONE
CAS Number: 152-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Femoston 1/10
Product Name: Femoston 1/10
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
CAS Number: 35380-71-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: DYDROGESTERONE
CAS Number: 152-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Irina ElovaaraAuthorisedFemale: yes
Male: no
Finland
418EUCTR2014-004412-11-GB16/01/201523 May 2016The purpose of this study is to examine the safety and efficacy of VSN16R and the performance in treating spasticity (tightness, stiffness or pull of muscles) in patients with Multiple Sclerosis (MS).A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects with Multiple SclerosisMultiple Sclerosis
MedDRA version: 19.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: VSN16R 100mg
Product Code: VSN16R
Pharmaceutical Form: Capsule
INN or Proposed INN: VSN16R
Other descriptive name: (R) 3-(5-Dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1- methylethyl) benzamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Canbex Therapeutics LtdAuthorisedFemale: yes
Male: yes
Phase 2United Kingdom
419NCT02284568January 12, 201511 June 2018A 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: Laquinimod;Drug: PlaceboTeva Branded Pharmaceutical Products, R&D Inc.Not recruiting25 Years55 YearsAll374Phase 2United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
420NCT02255656January 7, 201515 April 2019Phase 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 CompanyNot 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
421NCT02200770January 6, 201524 June 2019A Double-masked, Placebo-controlled Study With Open Label Period to Evaluate MEDI-551 in Neuromyelitis Optica and 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 DisordersBiological: MEDI-551;Other: PlaceboMedImmune LLCNot recruiting18 YearsN/AAll231Phase 2/Phase 3United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Greece;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;India;Netherlands;Portugal;Ukraine
422NCT02335450January 201511 April 2016Theory 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 UniversityNot recruiting19 YearsN/ABoth5N/AUnited States
423NCT02364986January 201513 June 2016Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple SclerosisImmune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: Rebif®;Drug: AvonexPD Dr. Marcus MüllerBfARM, Bonn;DZNE, BonnRecruiting18 Years65 YearsBoth50Phase 1Germany
424NCT02427776January 201516 December 2017A 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 SANot recruiting18 Years50 YearsAll2Phase 1/Phase 2Belgium
425NCT02606929January 201523 November 2015Use of Well Known Drugs for New Destination - MS Improvement (MSNT)Expanded Access Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Multiple Sclerosis Not Responding With Commonly Used TreatmentsMultiple Sclerosis;Autoimmune Diseases;Disseminated or Multiple Sclerosis Nos;Multiple Sclerosis, Acute Relapsing;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic ProgressiveDrug: Tetracycline - Statin - AntimycoticUniversità Popolare Homo & NaturaNot recruiting18 Years65 YearsBothPhase 0Italy
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
426EUCTR2015-000137-78-AT14 March 2016Mesenchymal stem cells therapy for patients with multiple sclerosisRandomised, double-blind, cross-over phase II study with intravenous autologous mesenchymal stem cells vs. placebo for multiple sclerosis patients in Austria (MESEMS Austria)multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Human autologous mesenchymal stem cells
Pharmaceutical Form: Infusion
INN or Proposed INN: MSC2015
Other descriptive name: UNDIFFERENTIATED AUTOLOGOUS MESENCHYMAL STEM CELLS
Concentration unit: Other
Concentration type: equal
Concentration number: 2 mio cells /kg -
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
SALK - Gemeinnützige Salzburger Landeskliniken Betriebsges. m.b.H., Christian-Doppler-Klinik, UK für Neurologie der PMUAuthorisedFemale: yes
Male: yes
Phase 2Austria
427NCT02254304December 31, 201411 June 2018Effectiveness 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 KGaAMerck Romania SRL, an affiliate of Merck KGaA, Darmstadt, GermanyNot recruiting18 Years65 YearsAll106Phase 4Germany
428EUCTR2014-000709-10-DE19/12/201418 June 2018Investigation on how alemtuzumab acts in patients with relapsing remitting multiple sclerosis.Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential - ALAIN01relapsing-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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Alemtuzumab
CAS Number: 216503-57-0
Other descriptive name: ALEMTUZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Universitätsklinikum MünsterAuthorisedFemale: yes
Male: yes
15Phase 4Germany
429EUCTR2014-002547-17-NL18/12/201414 March 2016Imaging of inflammation in the cortex of the brain in progressive MS patientsGrey matter microglial imaging with [18F]DPA-714 in progressive MS patients - [18F]DPA-714 PET in MSProgressive multiple sclerosis, both primary and secondary progressive
MedDRA version: 17.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: [18F]DPA-714
Pharmaceutical Form: Radiopharmaceutical precursor
INN or Proposed INN: [18F]DPA-714
Other descriptive name: [18F]DPA-714
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 250-
VU University Medical CenterNot RecruitingFemale: yes
Male: yes
Netherlands
430NCT01910259December 18, 201416 December 2017MS-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 WarwickNot recruiting25 Years65 YearsAll445Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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gender
Target_
size
PhaseCountries
431EUCTR2014-001012-19-NL17/12/201412 January 2015Effects of fingolimod on advanced brain measures and clinical measures in multiple sclerosisEffects of fingolimod on functional brain adaptation and clinical measures in multiple sclerosis - Effect of fingolimod on brain and cognitionRelapsing-remitting (RR) multiple sclerosis (MS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Gilenya
Pharmaceutical Form: Capsule
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Product Name: Interferon Beta
Pharmaceutical Form:
INN or Proposed INN: interferon beta-1b
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0-0.25
INN or Proposed INN: interferon beta-1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0-0.044
Trade Name: Copaxone
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 20-
VU University Medical CenterAuthorisedFemale: yes
Male: yes
Netherlands
432EUCTR2014-001081-99-BE16/12/20148 August 2016A first in human trial for evaluating both safety and preliminary efficacy of a single infusion of stimulated autologous CD4+ 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+ cells, stimulated and expanded ex vivo by a myelin oligodendrocyte glycoprotein (MOG) peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope (SCLEROLYM trial). First-in-human trial - SCLEROLYM TrialMultiple sclerosis is an immune-mediated inflammatory disease that attacks myelinated axons in the central nervous system. MS is characterized initially by episodes of reversible neurologic deficits. In most patients, these episodes are followed by progressive neurologic deterioration over time. Relapsing-remitting multiple sclerosis is characterized by recurrent attacks of neurologic dysfunction (relapses) followed by periods of complete or incomplete recovery (remission)
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] - Immune System Diseases [C20]
Product Name: SCLEROLYM
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Cytolytic CD4+ T cells
Other descriptive name: AUTOLOGOUS T-LYMPHOCYTES
Concentration unit: million organisms/ml million organisms/millilitre
Concentration type: range
Concentration number: 5-50
ImCyse S.ANot RecruitingFemale: yes
Male: yes
Phase 1;Phase 2Belgium
433NCT02294058December 3, 201416 December 2017Phase 3 Study of RPC1063 in Relapsing MSA 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: RPC1063;Drug: Beta interferonCelgeneNot recruiting18 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
434NCT02087631December 201422 October 2019Safety 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 CanadaNot recruiting18 Years65 YearsAll14Phase 1/Phase 2Canada
435NCT02142192December 201410 October 2016Natalizumab Subcutaneous Immunogenicity and Safety StudyA Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: natalizumabBiogenNot recruiting18 Years65 YearsBoth2Phase 2Belgium;Denmark;Germany;Italy
No.TrialIDDate_
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Last_Refreshed_
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436NCT02317263December 201415 August 2016A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple SclerosisMultiple SclerosisDrug: testosterone;Drug: placebo gelUniversity of California, Los AngelesNot recruiting18 Years60 YearsMale0Phase 2
437NCT02389426December 201428 April 2015Transcranial Doppler in Multiple SclerosisEvaluation of Cerebrovascular Hemodynamics With Transcranial Doppler and Near-infrared Spectroscopy in Patients With Multiple SclerosisMultiple SclerosisDevice: TCD baseline;Device: TCD after bosentan administration;Device: NIRS baseline;Device: NIRS after bosentan administrationUniversitair Ziekenhuis BrusselNot recruiting18 YearsN/ABoth30N/ABelgium
438EUCTR2014-001579-30-GB27/11/201424 October 2016A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as compared to 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) - ARPEGGIOPrimary Progressive Multiple Sclerosis
MedDRA version: 19.0 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LAQUINIMOD
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: Laquinimod Sodium (USAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Laquinimod
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LAQUINIMOD
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: Laquinimod Sodium (USAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Teva Pharmaceutical Industries Ltd.AuthorisedFemale: yes
Male: yes
375Phase 2United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom
439EUCTR2013-002378-26-SE13/11/201425 June 2018Switch To RItuXimab in MS extension An extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytesSwitch To RItuXimab in MS extension An extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSextThe original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial.
MedDRA version: 16.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera®
Product Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
Västerbottens Läns LandstingNot RecruitingFemale: yes
Male: yes
74Phase 2Sweden
440NCT02230969November 12, 20146 May 2019Plegridy Observational ProgramPlegridy™ (Peginterferon ß-1a) Real World Effectiveness and Safety Observational ProgramRelapsing Forms of Multiple SclerosisDrug: peginterferon beta-1aBiogenNot recruiting18 YearsN/AAll1210N/AUnited States;Australia;Austria;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom
No.TrialIDDate_
enrollement
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441EUCTR2013-004622-29-IT10/11/201411 April 2016Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) SubjectsA 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 SubjectsMultiple Sclerosis (MS)
MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri®
Product Name: AN100226, BG00002
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 300-
Trade Name: Gilenya
Product Name: Fingolimod
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
540France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden
442NCT02142764November 20149 January 2017Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis PatientsPreliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).Multiple SclerosisBiological: Blood samplesUniversity Hospital, BordeauxMerck Serono International SA;ADERANot recruiting18 YearsN/ABoth30N/AFrance
443NCT02253264November 201416 December 2017A 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 UniversityNot recruiting18 YearsN/AAll8Phase 1United States
444NCT02259361November 201419 February 2015Efficacy of Dalfampridine on Upper Extremity Function in Patients With MSEfficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot StudyMultiple SclerosisDrug: Sustained-release oral dalfampridine;Drug: PlaceboSheba Medical CenterNot recruiting18 Years70 YearsBoth30Phase 4Israel
445NCT02310048November 201423 March 2015Comparative Oral Bioavailability Study of MT-1303A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 in Healthy Male SubjectsRelapsing-remitting Multiple SclerosisDrug: MT-1303-FormA;Drug: MT-1303-FormBMitsubishi Tanabe Pharma CorporationNot recruiting18 Years55 YearsMale34Phase 1United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
446NCT02326935November 201411 June 2018Multi-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 CorporationNot recruiting18 Years65 YearsAll2Phase 1Cayman Islands
447EUCTR2014-002335-34-GB30/10/201422 May 2017Intravenous immunoglobulin vs standard therapy for treatment of transverse myelitisA multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children - STRiVETransverse myelitis (TM) (acute, first onset cases), including first presentation of neuromyelitis optica (NMO)
MedDRA version: 17.1 Level: PT Classification code 10028527 Term: Myelitis transverse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1 Level: PT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Intratect
Product Name: Intratect
Pharmaceutical Form: Solution for infusion
Guy's and St Thomas NHS Foundation TrustNot RecruitingFemale: yes
Male: yes
0Phase 3United Kingdom
448EUCTR2014-003669-97-BE27/10/201430 April 2018A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA.A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.Relapsing Forms of Multiple Sclerosis
MedDRA version: 17.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Biogen IdecNot RecruitingFemale: yes
Male: yes
10Phase 4Belgium
449EUCTR2014-000221-20-AT23/10/201423 July 2018Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical TrialTreatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical TrialClinically Isolated Syndrome and Relapsing-remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: RNS60
Product Code: RNS60
Pharmaceutical Form: Infusion
University Hospital ZürichNot RecruitingFemale: yes
Male: yes
16Phase 2Austria;Switzerland
450NCT02247310October 20, 201416 December 2017BETAEVAL 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: BETACONNECTBayerNot recruitingN/AN/AAll498N/AAustria;Belgium;Bosnia and Herzegovina;Croatia;Czechia;France;Greece;Hungary;Italy;Spain;Switzerland;Czech Republic;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
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agemin
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PhaseCountries
451NCT02096133October 13, 201416 December 2017Vitamin D3 and the Stress-axis in MSRegulation of the Stress-axis by Vitamin D3 in Subjects With Multiple Sclerosis; a Double-blinded, Randomized, Placebo-controlled StudyMultiple SclerosisDrug: Cholecalciferol;Other: Placebo comparatorAcademic MS Center LimburgNot recruiting18 YearsN/AFemale54Phase 2Netherlands
452NCT02104661October 201411 June 2018Protective 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 TrustNot recruiting18 Years60 YearsAll30Phase 2United Kingdom
453NCT02212886October 20141 April 2019Safety, 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.Not recruiting18 Years70 YearsAll25Phase 1/Phase 2Israel
454NCT02228213October 201416 December 2017Safety 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 ResearchNot recruiting18 Years70 YearsAll93Phase 2Australia;New Zealand
455NCT02234869October 201419 February 2015Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon TherapyOpen-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Patients With Relapsing Multiple Sclerosis Transitioning From Standard-of-care Subcutaneous Interferon Therapy to Peginterferon Beta-1a (BIIB017)Relapsing Multiple SclerosisDrug: Interferon Beta;Drug: BIIB017 (Peginterferon beta-1a)Biogen IdecNot recruiting18 Years65 YearsBoth0Phase 4
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
456NCT02269930October 201419 February 2015Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy VolunteersAn Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy VolunteersMultiple SclerosisDrug: peginterferon beta-1a;Drug: RebifBiogen IdecNot recruiting18 Years45 YearsBoth30Phase 1United States
457NCT02280096October 201428 December 2015Efficacy 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, MexicoNot recruiting18 Years60 YearsBoth24Phase 2Mexico
458NCT02282826October 201425 April 2016A First-in-human, 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 Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: GZ402668;Drug: placebo;Drug: acyclovirGenzyme, a Sanofi CompanyNot recruiting18 Years65 YearsBoth48Phase 1Germany
459NCT02286557October 201419 February 2015Testing the Effects of Methylphenidate on Multiple SclerosisTesting the Effects of Methylphenidate on Cognitive Fatigue in Multiple Sclerosis: a Double-blind, Placebo-controlled, Randomized Clinical TrialFatigue in Multiple SclerosisDrug: Methelphenidate;Drug: PlaceboKessler FoundationNot recruiting18 Years65 YearsBoth36Phase 2
460NCT02296346October 201426 August 2019Open-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 UtahMallinckrodtNot recruiting18 Years75 YearsAll13N/AUnited States
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
461EUCTR2011-005249-12-GB29/09/201410 September 2018Efficacy, 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 Extension - TERIKIDSMultiple Sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Genzyme CorporationAuthorisedFemale: yes
Male: yes
165Phase 3United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria
462NCT02232061September 29, 201414 October 2019Long-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 PharmaceuticalsRecruitingN/AN/AAll40Phase 4Belgium;Germany;Italy
463EUCTR2013-003600-40-GB15/09/20143 April 2017Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE)A 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 Sclerosis
MedDRA version: 17.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fampyra
Product Name: Fampridine
Product Code: BIIB041
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Current Sponsor code: BIIB041
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
590Phase 3United States;Serbia;Finland;Ukraine;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Poland;Bulgaria;Netherlands
464EUCTR2014-003209-14-FR01/09/20144 August 2015ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSISASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFFMULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: TYSABRI 300 mg solution à diluer pour perfusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Hôpitaux Universitaires de StrasbourgAuthorisedFemale: yes
Male: yes
France
465NCT02045732September 201419 October 2017A 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/kgPfizerNot recruiting18 Years55 YearsAll4Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
466NCT02193217September 20142 March 2015A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303Relapsing-remitting Multiple SclerosisDrug: MT-1303-Low;Drug: MT-1303-High;Drug: Fingolimod;Drug: PlaceboMitsubishi Tanabe Pharma CorporationNot recruiting18 Years55 YearsBoth81Phase 1United Kingdom
467NCT02273635September 201419 February 2015Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MSControlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple SclerosisPrimary Progressive Multiple Sclerosis;Multiple Sclerosis, Secondary ProgressiveDrug: Andrographolides;Drug: placeboInnobioscience SpAPontificia Universidad Catolica de Chile;University of Chile;Universidad Austral de ChileRecruiting18 Years70 YearsBoth68Phase 1/Phase 2Chile
468NCT02282878September 201416 December 2017The 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 UniversityRecruiting18 Years60 YearsAll25N/AUnited States
469NCT02287948September 201415 February 2016Wii FIT Balance Board to Recording Balance Parameters in Multiple Sclerosis SubjectsValidation Study for Using Wii FIT Balance Board to Recording Balance Parameters in Healthy Subjects and Multiple Sclerosis SubjectsPostural Balance;Multiple SclerosisDevice: Nintendo Wii Fit Balance BoardUniversity Hospital of FerraraNot recruiting18 Years80 YearsBoth40N/AItaly
470NCT02293967September 201423 March 2015Mass Balance Study of MT-1303An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.Relapsing-remitting Multiple SclerosisDrug: MT-1303Mitsubishi Tanabe Pharma CorporationNot recruiting30 Years65 YearsMale8Phase 1United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
471NCT02777060September 201430 May 2016Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome MeasuresExploring the Effectiveness of Sensor-based Balance Training on Patient Outcome MeasuresDiabetes;Cancer;Multiple Sclerosis;Arthritis;Parkinson's Disease;Cognitive Disorders;Brain Injury;StrokeProcedure: Exergame;Procedure: Home based balance trainingUniversity of ArizonaRecruiting18 YearsN/ABoth200N/AUnited States
472ChiCTR-ICR-150071772014-08-3018 April 2017A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic NeuritisA Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic NeuritisNeuromyelitis Optica associated Optic Neuritis1:Intravenous 100mg Rituximab, 1/week*4 ;2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (1000-1500mg/day);The Ophthalmology Department of the Chinese Peoples Liberation Army HospitalRecruiting1870Both1:30;2:30;New Treatment Measure Clinical StudyChina
473NCT02283853August 28, 201416 September 2019Phase 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-1aBiogenNot recruiting10 Years17 YearsAll142Phase 3Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Kuwait;Poland;Serbia;Spain;Sweden;Turkey;United Kingdom;United States;Argentina;Czech Republic;Romania
474EUCTR2011-005249-12-EE13/08/201428 August 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 Extension - TERIKIDSMultiple Sclerosis
MedDRA version: 17.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Genzyme CorporationAuthorisedFemale: yes
Male: yes
165United States;Estonia;Greece;Canada;Spain;Belgium;Lebanon;Turkey;Australia;Russian Federation;Israel;China
475NCT02073279August 5, 201417 June 2019Efficacy 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 PharmaceuticalNot recruiting18 Years74 YearsAll95Phase 3United States;Bulgaria;Canada;Croatia;Georgia;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Romania;Taiwan;Turkey;Ukraine;Bosnia and Herzegovina;Puerto Rico;Singapore
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
476NCT02209467August 201417 November 2015Balance and Falls in Multiple SclerosisBalance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of KinsMultiple SclerosisOther: Group balance trainingÖrebro County CouncilNot recruiting18 YearsN/ABoth52N/ASweden
477NCT02218879August 201412 September 2016Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MSRestoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: TecfideraYale UniversityNot recruiting18 Years60 YearsBoth7N/AUnited States
478EUCTR2014-000092-62-BE30/07/20148 August 2016Management 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. - EMERALDRelapsing-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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: alemtuzumab
CAS Number: 216503-57-0
Current Sponsor code: GZ402673
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Genzyme CorporationNot RecruitingFemale: yes
Male: yes
56Phase 4France;Spain;Belgium;Netherlands;Switzerland
479NCT02201108July 16, 20147 October 2019Efficacy, 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 CompanyNot recruiting10 Years18 YearsAll165Phase 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
480NCT02159573July 201413 June 2016Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)Relapsing-Remitting Multiple SclerosisBiological: natalizumab;Drug: dimethyl fumarateBiogenNot recruiting18 YearsN/ABoth530N/AUnited States
No.TrialIDDate_
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Last_Refreshed_
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481NCT02201849July 201419 February 2015A 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: PlaceboAlkermes, Inc.Not recruiting18 Years55 YearsBoth104Phase 1United States
482NCT02217982July 201416 December 2017Pilot 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, LLCBiogenNot recruiting18 YearsN/AAll5Phase 4United States
483NCT02727907July 20148 August 2016Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple SclerosisInternational, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: BCD-033 (interferon beta 1a);Drug: Rebif (interferon beta 1a);Drug: PlaceboBiocadNot recruiting18 Years55 YearsBoth147Phase 2/Phase 3Russian Federation
484EUCTR2013-003126-83-DE23/06/20147 October 2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosisRelapsing multiple sclerosis
MedDRA version: 16.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ceralifimod
CAS Number: 891859-12-4
Current Sponsor code: MSC2430913A or ONO-4641 (to be used as synonyms)
Other descriptive name: ONO-4641
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.05-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Avonex
Product Name: Avonex
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: Avonex
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Intramuscular use
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ceralifimod
CAS Number: 891859-12-4
Current Sponsor code: MSC2430913A or ONO-4641 (to be used as synonyms)
Other descriptive name: ONO-4641
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Merck KGaANot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
485NCT02121444June 23, 201416 December 2017BAY86-5046 (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.BayerNot recruiting18 YearsN/AAll151N/AGermany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486EUCTR2013-002324-16-CZ13/06/201422 October 2018Study of efficacy and safety of VAY736 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 sclerosisrelapsing-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 Code: VAY736
Pharmaceutical Form: Powder for concentrate for solution for infusion
Current Sponsor code: VAY736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Czech Republic;Poland;Ukraine;Russian Federation
487EUCTR2013-002318-11-SE05/06/201423 October 2017Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECTRelapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Trade Name: AVONEX
Product Name: Avonex
Pharmaceutical Form: Injection
INN or Proposed INN: Interferon beta-1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 7.5-30
Biogen Idec Research LimitedAuthorisedFemale: yes
Male: yes
132Phase 3Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden
488EUCTR2013-002324-16-PL04/06/201412 November 2018Study of efficacy and safety of VAY736 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 sclerosisrelapsing-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 Code: VAY736
Pharmaceutical Form: Powder for concentrate for solution for infusion
Current Sponsor code: VAY736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Czech Republic;Poland;Ukraine;Russian Federation
489EUCTR2011-005249-12-ES03/06/201428 February 2019A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple 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 - TERIKIDSMultiple Sclerosis
MedDRA version: 16.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Genzyme CorporationNot Recruiting Female: yes
Male: yes
165Phase 3Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China
490NCT01883661June 201419 February 2015Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)Role of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (MNCs) In Patient With Multiple Sclerosis .It is Self Funded (Patients' Own Funding) Clinical TrialMultiple SclerosisBiological: BMMNCChaitanya Hospital, PuneRecruiting18 Years65 YearsBoth15Phase 1/Phase 2India
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
491NCT01941004June 201416 December 2017Safety 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 PharmaceuticalsNot recruiting18 Years50 YearsAll0Phase 3
492NCT02117050June 201419 October 2017RESOunD: 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 SeronoNot recruiting18 Years65 YearsAll1Phase 4United States
493NCT02133664June 201416 December 2017Lipoic 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 SocietyNot recruiting18 Years65 YearsAll54Phase 1/Phase 2United States
494NCT02258217June 201416 December 2017Tolerability 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: ActharOhioHealthNot recruiting18 YearsN/AAll30N/AUnited States
495EUCTR2013-003752-21-GB19/05/20147 January 2019A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of SA237 in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0 Level: LLT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SA237-120/vial
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Satralizumab (r-INN)
CAS Number: Not known
Current Sponsor code: SA237
Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SA237-120 PFS with NSD
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Satralizumab (r-INN)
CAS Number: Not known
Current Sponsor code: SA237
Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Chugai Pharmaceutical Co. LtdAuthorisedFemale: yes
Male: yes
70Phase 3France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
496JPRN-UMIN0000134532014/05/107 October 2019A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibodyA multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody - RIN-1Neuromyelitis opticaRituximab intravenous infusion
Placebo
Clinical Research Center, NHO Utano National HospitalZenyaku Kogyo Co., Ltd.Not Recruiting16years-old80years-oldMale and Female40Phase 2,3Japan
497EUCTR2013-001486-17-DE06/05/201425 April 2016TOLERATE - A Study that evaluates the Gastrointestinal Tolerability of DMF in Multiple Sclerosis PatientsA Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects with Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)Relapsing-Remitting Multiple Sclerosis
MedDRA version: 18.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
Germany
498EUCTR2013-001895-40-IE02/05/201418 January 2016A study to evaluate the effect of aspirin on flushing in patients with RRMS treated with TecfideraA Phase 4, Randomized, Double-Blind Study with a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects with Relapsing-Remitting Multiple Sclerosis Treated with Tecfidera™ (dimethyl fumarate) delayed-release capsules (ASSURE) - ASSURERelapsing-Remitting Multiple Sclerosis
MedDRA version: 16.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 16.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Trade Name: Micropirin
Pharmaceutical Form: Capsule
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Other descriptive name: ASA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
240Phase 4Ireland;United Kingdom
499JPRN-JapicCTI-14244701/5/201416 July 2019Exploring 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 SclerosisSecondary Progressive Multiple SclerosisIntervention name : BAF312
INN of the intervention : Siponimod
Dosage And administration of the intervention : BAF312 will be provided in a dose titration from 0.25 mg to a 2 mg dose.
Control intervention name : Placebo
Dosage And administration of the control intervention : Matching Placebo administered orally.
Novartis Pharma K.K.Not Recruiting1860BOTH1530Phase 3
500NCT02046629May 201419 February 2015A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese VolunteersAn Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese SubjectsMultiple SclerosisDrug: Teriflunomide HMR1726;Drug: cholestyramineSanofiNot recruiting18 Years45 YearsBoth12Phase 1China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
501NCT02064816May 201416 December 2017A 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 KGaANot recruiting18 Years60 YearsAll212Phase 4Germany
502NCT02086188May 201411 November 2019Study 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 IncNot recruiting18 YearsN/AAll28Phase 4United States
503NCT02143167May 20143 September 2018Resistance 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;BiogenNot recruiting18 Years60 YearsAll40Phase 4Denmark
504NCT02579681April 30, 201416 December 2017Study 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 fumarateBiogenNot recruiting18 YearsN/AAll221Phase 3Italy
505EUCTR2014-000296-12-FI15/04/201428 April 2014N/AN/AMultiple sclerosis
MedDRA version: 16.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Trade Name: Gilenya
Product Name: Fingolimodi
Pharmaceutical Form: Capsule, hard
Turku University HospitalAuthorisedFemale: yes
Male: yes
Finland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
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agemin
Inclusion_
agemax
Inclusion_
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Target_
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PhaseCountries
506EUCTR2012-000734-19-ES10/04/201414 April 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 - EMMESMultiple 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
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Autologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved
Other descriptive name: Mesenchymal Stem Cells
Concentration unit: U unit(s)
Concentration type: range
Concentration number: 800000-1200000
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intravenous use
Banc de Sang i TeixitsAuthorisedFemale: yes
Male: yes
Spain
507EUCTR2013-002660-17-IT09/04/201411 April 2016Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosisLong-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSSmultiple sclerosis
MedDRA version: 16.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolmod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Novartis Farma SpANot RecruitingFemale: yes
Male: yes
281Phase 2France;Portugal;Canada;Finland;Spain;Poland;Denmark;Germany;United Kingdom;Switzerland;Italy
508NCT01933802April 201411 June 2018Intrathecal 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 YorkNot recruiting18 Years70 YearsAll20Phase 1United States
509NCT01973517April 201417 September 2018High-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 UniversityNot recruiting18 YearsN/AAll0Phase 3United States
510NCT02865018April 201422 August 2016Neuromyelitis Optica (NMO) & CetirizineAn Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis OpticaNeuromyelitis OpticaDrug: cetirizineIcahn School of Medicine at Mount SinaiGuthy Jackson FoundationNot recruiting18 Years85 YearsBoth16Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
511EUCTR2013-002419-87-GB18/03/201428 February 2019PROXIMUS (PRotective role of OXcabazepine In MUltiple Sclerosis)Oxcarbazepine as a neuroprotective agent in MS: phase 2a trial - PROXIMUS - PRotective role of OXcabazepine In MUltiple SclerosisMultiple sclerosis
MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Trileptal
Product Name: Oxcarbazepine
Other descriptive name: Trileptal
Concentration unit: mg milligram(s)
Concentration number: 150-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Queen Mary University LondonNot Recruiting Female: yes
Male: yes
30Phase 2United Kingdom
512EUCTR2013-002351-15-EE13/03/20147 October 2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosisRelapsing remitting multiple sclerosis
MedDRA version: 16.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ceralifimod
CAS Number: 891859-12-4
Current Sponsor code: MSC2430913A or ONO-4641 (to be used as synonyms)
Other descriptive name: ONO-4641
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.05-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Avonex
Product Name: Avonex
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: Avonex
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Intramuscular use
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ceralifmod
CAS Number: 891859-12-4
Current Sponsor code: MSC2430913A or ONO-4641 (to be used as synonyms)
Other descriptive name: ONO-4641
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Merck KGaANot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
513EUCTR2013-004616-21-DE13/03/201414 March 2016A study to assess immune function and typical disease characteristics in patients with multiple sclerosis, when switching from the medication Natalizumab to the medication Gilenya.A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod) - ToFingo Successorrelapsing remitting multiple sclerosis
MedDRA version: 18.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Trade Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Current Sponsor code: BG00002
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Universitätsklinikum MünsterNot RecruitingFemale: yes
Male: yes
Germany
514NCT02087813March 201423 April 2019Pilot 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 UniversityNot recruiting18 Years75 YearsAll0Phase 1United States
515NCT02137109March 201426 October 2015Safety and Efficacy in Pediatric MS Patients Prescribed TysabriMeta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple SclerosisMultiple SclerosisDrug: natalizumabBiogenNot recruitingN/A18 YearsBoth400N/A
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
516NCT02208050March 201410 September 2018A Double Blind, Randomized, Placebo Controlled, Crossover Study of the Effectiveness of Oral Fampridine in Improving Upper Limb Function in Progressive Multiple SclerosisA 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 DublinNot recruiting18 Years70 YearsAll66Phase 4Ireland
517NCT02028884February 20, 20149 September 2019Efficacy 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 PharmaceuticalNot recruiting12 Years74 YearsAll83Phase 3United States;France;Germany;Hungary;Italy;Japan;Poland;Spain;Taiwan;Ukraine;United Kingdom
518NCT02084121February 201430 September 2019Allogeneic 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 InfusionUniversity of LouisvilleDuke UniversityNot recruiting3 YearsN/AMalePhase 4United States
519NCT02166346February 201411 June 2018Safety 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 TherapeuticsNot recruiting18 Years70 YearsAll24Phase 2United States
520NCT02849782February 201420 August 2018Short 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 BesanconRecruiting18 Years80 YearsAll98Phase 4France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
521NCT03033355February 201411 June 2018Central Nervous System Changes Following BotulinumtoxinA Injection in the BladderA Prospective Study of Higher Neural Control Changes Following Intradetrusor Injection of BotulinumtoxinA in Patients With Multiple Sclerosis and Lower Urinary Tract Symptoms.Multiple Sclerosis;Lower Urinary Tract Symptoms;Neurogenic Bladder;Detrusor, Overactive;Urge IncontinenceDrug: Intradetrusor injection of Botulinum Toxin-ARose Khavari, M.D.The Methodist Hospital SystemRecruiting18 YearsN/AFemale50Phase 1United States
522EUCTR2012-005450-30-AT08/01/201427 October 2014Investigation of neutralising antibodies against interferon-beta in patients with multiple sclerosis, in order to find markers to predict the development of these antibodies and minimize the risk of ineffective therapyAnti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment - ABIRISKDevelopment of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Avonex
Pharmaceutical Form: Injection
INN or Proposed INN: Interferon-beta 1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Trade Name: Rebif
Pharmaceutical Form: Injection
INN or Proposed INN: Interferon-beta 1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 44-
Trade Name: Betaferon
Pharmaceutical Form: Injection
INN or Proposed INN: Interferon-beta 1b
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Trade Name: Extavia
Pharmaceutical Form: Injection
INN or Proposed INN: Interferon-beta 1b
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Trade Name: Rebif
Pharmaceutical Form: Injection
INN or Proposed INN: Interferon-beta 1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 44-
Trade Name: Rebif
Pharmaceutical Form: Injection
INN or Proposed INN: Interferon-beta 1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 44-
Medizinische Universität InnsbruckAuthorisedFemale: yes
Male: yes
100Austria
523JPRN-UMIN0000127052014/01/072 April 2019The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosisRelapsing-remitting multiple sclerosisTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.Department of Immunology, National Institute of Neuroscience, NCNPRecruiting20years-old65years-oldMale and Female10Not applicableJapan
524NCT01892345January 20141 April 2019A Double Blind Trial To Evaluate The Safety And Efficacy Of Eculizumab In Relapsing NMO Patients (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: EculizumabAlexion PharmaceuticalsNot recruiting18 YearsN/AAll143Phase 3United States;Argentina;Australia;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;Singapore
525NCT02034188January 201416 December 2017Feasibility 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 BiosciencesNot recruiting18 Years55 YearsAll20Phase 1/Phase 2Panama
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
526NCT02040298January 201425 April 2016Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple SclerosisA Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Crossover Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Clemastine;Drug: PlaceboUniversity of California, San FranciscoNot recruiting18 Years60 YearsBoth50Phase 2United States
527EUCTR2013-004626-28-FI20/12/201323 December 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
Pharmaceutical Form: Solution for injection
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 6-
Trade Name: Gilenya
Product Name: Fingolimodi
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-55-9
Other descriptive name: FINGOLIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,5-
Trade Name: Avonex
Pharmaceutical Form: Solution for injection
Trade Name: Betaferon
Pharmaceutical Form: Concentrate and solvent for solution for injection
Trade Name: Copaxone
Pharmaceutical Form: Solution for injection in pre-filled syringe
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: Lemtrada
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 216503-57-0
Other descriptive name: ALEMTUZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-
Turku University HospitalAuthorisedFemale: yes
Male: yes
Finland
528NCT02038049December 20, 20134 November 2019A 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 PharmaceuticalsNot recruiting18 Years55 YearsAll8Phase 2United States;Czechia;Ukraine;Czech Republic;Germany;Poland;Russian Federation
529EUCTR2013-002283-25-CZ18/12/201310 July 2015A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA 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 Sclerosis - Efficacy, safety, and tolerability of plovamer acetateRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-
Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Copaxone
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Merck KGaANot RecruitingFemale: yes
Male: yes
550Phase 2Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria
530EUCTR2013-002558-64-IT18/12/201316 October 2017improvement of cognitive performance after administration of fampridina in patients with multiple sclerosisA randomised, placebo-controlled trial investigating the role of fampiridina in improving cognitive function of patients with multiple sclerosis.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: fampyra
Product Name: FAMPYRA
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Current Sponsor code: CP1/2013
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
dipartimento di neurologia e psichiatriaNot RecruitingFemale: yes
Male: yes
123Phase 4Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
531EUCTR2013-001151-12-DE12/12/201322 October 2018EXTENSION 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ECULIZUMAB
CAS Number: 219685-50-4
Current Sponsor code: h5G1.1-mAb
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Alexion Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
132Phase 3United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
532EUCTR2013-002916-28-LV12/12/201328 February 2019An 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 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 SclerosisRelapsing Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10067063 Term: Progressive relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ATX-MS-1467
Product Code: MSC2358825A
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: MSC2304479A
CAS Number: 1147979-29-0
Current Sponsor code: ATX-MS-01
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: MSC2304480A
CAS Number: 1147979-31-4
Current Sponsor code: ATX-MS-04
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: MSC2304481A
CAS Number: 1147979-32-5
Current Sponsor code: ATX-MS-06
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: MSC2304482A
CAS Number: 1147979-30-3
Current Sponsor code: ATX-MS-07
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Merck KGaAAuthorised Female: yes
Male: yes
20Phase 2Russian Federation;Latvia
533NCT02047734December 3, 201315 July 2019Efficacy 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 placeboCelgeneNot recruiting18 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
534JPRN-jRCTs03118034602/12/20137 October 2019Treatment with an anti-interleukin-6 receptor antibody for multiple sclerosisThe efficacy and safety of an anti-interluekin-6 receptor antibody in multiple sclerosismultiple sclerosis;D009103Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight.Takashi YamamuraNot Recruiting>= 20age old<= 65age oldBoth6N/Anone
535NCT02035514December 20139 January 2017Phase I-II Clinical Trial With Autologous Bone Marrow Derived Mesenchymal Stem Cells for the Therapy of Multiple SclerosisPhase I-II Clinical Trial With Autologous Bone Marrow Derived Mesenchymal Stem Cells for the Therapy of Multiple SclerosisRelapsing Remitting Multiple Sclerosis (RRMS)Biological: Bone marrow autologous mesenchymal stem cells transplantationGermans Trias i Pujol HospitalMinisterio de Sanidad, Servicios Sociales e IgualdadNot recruiting18 Years50 YearsBoth9Phase 1/Phase 2Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
536NCT02146534December 201318 March 2019Prolonged-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.Not recruiting18 YearsN/AAll44Phase 4Canada
537NCT02047097November 30, 201322 July 2019Dimethyl 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 fumarateBiogenRecruiting18 YearsN/AAll5600Phase 4United 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
538EUCTR2013-000529-30-GB27/11/201323 December 2013prolonged-release oral fampridine in Neuromyelitis Optica (NMO), Pilot feasibility StudyA pilot study to assess efficacy of prolonged-Release oral fampridine on ambulation and visual function in Neuromyelitis Optica - Assessment of fampridine-PR in NMONeuromyelitis optica (NMO);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Fampyra
Product Name: fampyra 10mg prolonged release tablets
Pharmaceutical Form: Prolonged-release tablet
Walton Centre Foundation TrustAuthorisedFemale: yes
Male: yes
0United Kingdom
539EUCTR2013-002082-19-BE25/11/20138 August 2016A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTORelapsing remitting multiple sclerosis
MedDRA version: 16.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LAQUINIMOD
CAS Number: 248281-84-7
Current Sponsor code: TV-5600
Other descriptive name: Laquinimod Sodium (USAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Avonex
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Current Sponsor code: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Teva Pharmaceutical Industries, Ltd.Not RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
540EUCTR2013-002283-25-HU25/11/201316 March 2015A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA 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 Sclerosis - Efficacy, safety, and tolerability of plovamer acetateRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-
Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Copaxone
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Merck KGaANot RecruitingFemale: yes
Male: yes
550Phase 2Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria
No.TrialIDDate_
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541EUCTR2013-001439-34-FI18/11/201313 June 2016Using 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) Patients - TERI-PROMultiple Sclerosis
MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Genzyme CorporationNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden
542NCT01939002November 201319 October 2017Characterize 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: naproxenBiogenNot recruiting18 Years65 YearsAll251Phase 3United States
543NCT01968902November 201316 December 2017Safety 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.Not recruiting18 Years65 YearsAll27Phase 4United States
544NCT01982942November 201311 June 2018Safety, 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 SocietyNot recruiting21 Years65 YearsAll255Phase 2United States
545NCT02048358November 201319 February 2015Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) PatientsRandomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201Healthy Volunteers;Multiple SclerosisDrug: 2B3-201;Drug: Placebo;Drug: Methylprednisolone hemisuccinateBBB-Therapeutics B.V.Not recruiting18 Years65 YearsBoth47Phase 1Netherlands
No.TrialIDDate_
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546NCT03133403November 201311 June 2018Hematopoietic 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 TrustRecruiting18 Years55 YearsAll5Phase 2/Phase 3United Kingdom
547NCT01930708October 31, 201315 July 2019A 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 fumarateBiogenNot recruiting18 YearsN/AAll1114Phase 4Austria;Belgium;Canada;Czechia;France;Hungary;Italy;Portugal;Slovakia;Slovenia;Spain;Czech Republic
548NCT01911767October 30, 20131 April 2019Biogen Multiple Sclerosis Pregnancy Exposure RegistryBiogen Idec Multiple Sclerosis Pregnancy Exposure RegistryMultiple Sclerosis;Exposure During PregnancyDrug: Dimethyl fumarate;Drug: Peginterferon beta-1aBiogenRecruitingN/AN/AFemale1125Phase 2United States;Australia;Germany;Ireland;Italy;Spain;United Kingdom;Canada
549NCT01326715October 17, 201314 October 2019Manganese-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)Not recruiting18 Years70 YearsAll15Phase 1United States
550NCT01863888October 201323 March 2015Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple SclerosisExploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: teriflunomide HMR1726;Drug: cholestyramine;Drug: charcoalSanofiNot recruiting18 Years55 YearsBoth70Phase 3Belgium;Germany;Netherlands
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
551NCT01868048October 201322 August 2016Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis.A Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis.Spasticity;Multiple SclerosisDrug: Sativex;Drug: PlaceboGW Research LtdNot recruiting18 YearsN/ABoth0Phase 3
552NCT01911377October 201312 October 2015Botulinum 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 ManitobaAllerganNot recruiting18 Years70 YearsBoth12Phase 2Canada
553NCT01950234October 201311 November 2019ACTH 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 MinnesotaMallinckrodtNot recruiting18 YearsN/AAll100Phase 2United States
554NCT01970410October 201311 June 2018Safety and Effectiveness of Switching Relapsing MS Patients Treated With Natalizumab at Risk for PML to TeriflunomideSwitching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective?Multiple SclerosisDrug: teriflunomideMultiple Sclerosis Center of Northeastern New YorkProvidence Multiple Sclerosis CenterNot recruiting21 Years60 YearsAll70Phase 4United States
555NCT02220244October 201316 December 2017Effect 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 SANot recruiting18 Years75 YearsAll105Phase 3France;United Kingdom
No.TrialIDDate_
enrollement
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PhaseCountries
556NCT02220933October 201316 December 2017Effect 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 SANot recruiting18 Years75 YearsAll144Phase 3France
557NCT02753088October 201314 November 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: PlaceboBiocadNot recruiting18 Years55 YearsBoth158Phase 3
558EUCTR2012-005324-16-BE27/08/201317 August 2015Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple SclerosisExploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMICmultiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Current Sponsor code: HMR1726
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Genzyme CorporationNot RecruitingFemale: yes
Male: yes
68Belgium;Germany;Netherlands
559EUCTR2013-001409-10-DK08/08/201317 October 2016Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MSFATIMS - Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MS - FATIMSMultiple Sclerosis
MedDRA version: 14.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fampyra
Product Name: Fampyra
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Odense University HospitalAuthorisedFemale: yes
Male: yes
Phase 4Denmark
560JPRN-UMIN0000100942013/08/012 April 2019A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis opticaneuromyelitis optica4.8mg/kg Sivelestat Sodium will administered constantly for 5 days in combination with 3 days intravenous methyl-prednisolone administration to sero-positive neuromyelitis optica patients who relapsed within 72 hours before starting treatment.Tohoku University HospitalNot Recruiting20years-old55years-oldMale and Female10Phase 1,2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
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561NCT01890655August 201318 April 2016Extension Study of MT-1303A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 StudyRelapsing-remitting Multiple SclerosisDrug: MT-1303-Low;Drug: MT-1303-Middle;Drug: MT-1303-HighMitsubishi Tanabe Pharma CorporationNot recruiting18 Years60 YearsBoth367Phase 2Belgium;Bulgaria;Canada;Croatia;Czech Republic;Finland;Germany;Hungary;Italy;Lithuania;Poland;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom
562NCT01903291August 20138 August 2016Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMSA Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer AcetateRelapsing Forms of Multiple SclerosisDrug: dimethyl fumarateBiogenNot recruiting18 YearsN/ABoth333N/AUnited States
563NCT01906684August 201319 February 2015Comprehensive Analysis of Relapse in Multiple SclerosisComprehensive Analysis of Relapse in Multiple SclerosisMultiple SclerosisDrug: Acthar GelTanner Foundation for Multiple SclerosisQuestcor Pharmaceuticals, Inc.;Auburn University MRI Research Center;iReportoire IncNot recruiting19 Years65 YearsBoth20N/AUnited States
564NCT01917019August 201316 December 2017A 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)BiogenNot recruiting18 Years70 YearsAll101Phase 3Japan
565NCT02141022August 201323 May 2016Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With GilenyaA Pilot Study of Plasticity-Based and Adaptive Cognitive Remediation in Adults With Multiple Sclerosis Treated With GilenyaMultiple Sclerosis;Cognitive Deficits;Gilenya Modifying Therapy for MSOther: plasticity-based computerized cognitive remediation program;Drug: GileynaStony Brook UniversityNovartisNot recruiting18 Years70 YearsBoth20N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
566NCT02290444August 201310 December 2018Effects 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 BuffaloNot recruiting18 Years65 YearsAll60Phase 3United States
567NCT02225977July 31, 20133 September 2018Assessing 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 CaliforniaNot recruiting18 Years65 YearsAll125Phase 3United States
568EUCTR2012-004807-10-DE17/07/201323 July 2018Relapse Escalation treatment trial in Optic Neuritis (RESCON): Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic NeuritisRelapse Escalation treatment trial in Optic Neuritis (RESCON): Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic NeuritisMS patients who suffer from severe Optic Neuritis without satisfying improvement after treatment with steroids (3-5 days with 1 g daily at least 7 days prior to randomization) and with persisting visual acuity < 0.7, duration of symptoms should be = 4 weeks
MedDRA version: 14.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1 Level: LLT Classification code 10070425 Term: Multiple sclerosis exacerbation System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
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: Urbason® solubile forte 1000 mg
Product Name: Methylprednisolone
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Methylprednisolone
CAS Number: 83-43-2
Other descriptive name: METHYLPREDNISOLONE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
University Medical Center Hamburg EppendorfNot RecruitingFemale: yes
Male: yes
40Phase 2Germany
569JPRN-UMIN0000111112013/07/162 April 2019Spinal blood flow and metabolism in neurological diseasesmotor 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 SciencesRecruiting20years-oldNot applicableMale and Female70Not applicableJapan
570NCT01817166July 16, 201315 July 2019Efficacy 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 NimesRecruiting18 Years56 YearsAll316Phase 3France
No.TrialIDDate_
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571EUCTR2012-005086-12-AT05/07/201311 April 2016Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trialrelapsing 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: Octagam 50 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
CAS Number: 308067-58-5
Current Sponsor code: Octagam 5%
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Copaxone 20 mg/ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: INTERFERON BETA-1a
CAS Number: 145258-61-3
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 12-
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: INTERFERON BETA-1b
CAS Number: 145155-23-3
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: INTERFERON BETA-1a
CAS Number: 145155-23-3
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Octapharma AGNot RecruitingFemale: yes
Male: yes
216Phase 3bHungary;Poland;Austria;Russian Federation;Bulgaria;Germany
572NCT01647880July 201310 December 2018MOdification 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, BerlinNot recruiting18 Years55 YearsAll15Phase 2/Phase 3Germany
573NCT01710228July 20139 January 2017Alternative 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, GermanyNot recruiting18 Years60 YearsBoth0Phase 2United States
574NCT01896700July 201311 June 2018Methylphenidate to Improve Balance and Walking in MSMethylphenidate to Improve Balance and Walking in MSMultiple SclerosisDrug: Methylphenidate;Drug: PlaceboOregon Health and Science UniversityPortland VA Medical CenterNot recruiting20 Years65 YearsAll24Phase 2/Phase 3United States
575NCT01900093July 201316 December 2017Evaluation 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
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576NCT02048072July 201319 October 2017Evaluation 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 VehoffNot recruiting18 Years60 YearsAll33Phase 4Switzerland
577