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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:1,426(DrugBank:306),標的遺伝子数:216,標的パスウェイ数:210] 

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 of the data. 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"
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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
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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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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
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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_
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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
No.TrialIDDate_
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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
577EUCTR2011-006262-40-CZ18/06/20134 July 2016A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex®A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex®Relapsing forms of multiple sclerosis
MedDRA version: 19.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIIB033
Product Code: BIIB033
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BIIB033
Other descriptive name: Human anti-LINGO-1 monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Avonex
Product Name: AVONEX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
CAS Number: 145258-61-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
396Phase 2Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom
578EUCTR2013-001422-25-IT11/06/201326 February 2018Study to be conducted only in Italy to evaluate the effect of the treatment with BG00012 on cognitive function in patients with Relapsing Remitting Multiple SclerosisSingle country study assessing cognition in Relapsing Remitting Multiple Sclerosis patients treated with BG00012Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: dimethyl fumarate [DMF]
Product Code: BG00012
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dimetilfumarato
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 Italia S.r.l.AuthorisedFemale: yes
Male: yes
220Phase 3Italy
579JPRN-JapicCTI-13217801/6/20132 April 2019A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple SclerosisA Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple SclerosisMultiple SclerosisIntervention name : AIN457
INN of the intervention : secukinumab
Dosage And administration of the intervention : AIN457 will be administered intravenously. Patients will be randomized to AIN457 Low/Middle/High dose.
Control intervention name : Placebo
Dosage And administration of the control intervention : Matching placebo will be administered intravenously.
Novartis Pharma K.K.1855BOTH380Phase 2
580NCT03216915June 1, 201321 January 2019Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple SclerosisFINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple SclerosisMultiple SclerosisDrug: Gilenya®; Novartis Pharmaceuticals CorporationUniversitätsklinikum Hamburg-EppendorfRecruiting18 YearsN/AAll100Phase 2Germany
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PhaseCountries
581NCT01621269June 201316 December 2017ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against InterferonA 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon BetaMultiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNot recruiting18 Years65 YearsAll0Phase 4Germany
582NCT01651520June 201316 December 2017Prognosis Value of the Neuronal Damage in Early Multiple SclerosisPrognosis Value of the Neuronal Damage Detected by Positrons Emission Tomography (PET) With 11C-Flumazenil in Early Multiple Sclerosis.Multiple SclerosisDrug: PET with 11C-FlumazenilAssistance Publique - Hôpitaux de ParisNot recruiting18 Years55 YearsAll60N/AFrance
583NCT01717664June 20138 August 2016Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS)A Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of Fixed Dose Combination RHB-104 as Add-On Therapy to Interferon Beta-1a in Patients Treated for Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: RHB-104RedHill Biopharma LimitedNot recruiting18 YearsN/ABoth18Phase 2Israel
584NCT01777412June 201319 October 2017Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO ExacerbationsAn Open-label Phase 1b Study of Avastin® (Bevacizumab) for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD).Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: BevacizumabJohns Hopkins UniversityGenentech, Inc.;Guthy Jackson Charitable FoundationNot recruiting18 Years70 YearsAll10Phase 1United States
585NCT01874145June 201319 October 2017Safety and Tolerability of Glatiramer AcetateAn Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: GA 20 mg/mL;Drug: GA 40 mg/mLTeva Pharmaceutical IndustriesNot recruiting18 YearsN/AAll209Phase 3United 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
586NCT01895335June 201319 October 2017Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) PatientsMultiple SclerosisDrug: TeriflunomideSanofiNot recruiting18 YearsN/AAll1001Phase 4United States;Austria;Belgium;Canada;Chile;Finland;France;Germany;Greece;Italy;Norway;Spain;Sweden;United Kingdom
587EUCTR2012-003176-39-DE31/05/201311 December 2017Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTENDRelapsing-remitting Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab
Current Sponsor code: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
1600Phase 3Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden
588EUCTR2012-004040-30-AT24/05/201327 October 2014Natalizumab de-escalation to interferon-beta-1b in patients with relapsing-remitting multiple sclerosis: A multicenter studyNatalizumab de-escalation to interferon-beta-1b in patients with relapsing-remitting multiple sclerosis: A multicenter studyrelapse-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: BETAFERON® (interferon beta-1b)
Product Name: Betaferon
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Betaferon
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Ospedale Regionale di LuganoAuthorisedFemale: yes
Male: yes
72Austria;Switzerland
589NCT01854359May 11, 201319 November 2018Idebenone for Primary Progressive Multiple SclerosisOpen Label Extension Trial of Idebenone for Primary Progressive Multiple SclerosisMultiple Sclerosis;Primary Progressive Multiple SclerosisDrug: IdebenoneNational Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 YearsN/AAll61Phase 1/Phase 2United States
590EUCTR2011-005677-23-LT10/05/20137 January 2019Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension PhaseRelapsing multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product 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-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Avonex
Pharmaceutical Form: Solution for injection in pre-filled syringe
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: 60-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Intramuscular use
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: 0.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Service AGAuthorisedFemale: yes
Male: yes
190Phase 3Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;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
591NCT01838174May 20134 November 2019A Trial of Neuroprotection With ACTH in Acute Optic NeuritisA Phase IV Trial of Neuroprotection With ACTH in Acute Optic NeuritisMultiple SclerosisDrug: ACTHAR Gel (ACTH);Drug: IV methylprednisolone (steroids)University of Colorado, DenverMallinckrodt;University of PennsylvaniaRecruiting18 Years55 YearsAll100Phase 4United States
592NCT01845584May 201316 December 2017Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.Neuromyelitis Optica Spectrum DisorderDrug: NPB-01Nihon Pharmaceutical Co., LtdNot recruiting20 YearsN/AAll7Phase 2Japan
593NCT01873417May 201316 December 2017Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United StatesA Multicenter, Open-Label, Single-Arm Study of Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera™ (Dimethyl Fumarate) Delayed-release CapsulesRelapsing Forms of Multiple SclerosisDrug: BG00012 (DMF)BiogenNot recruiting18 YearsN/AAll237Phase 4United States
594EUCTR2012-004019-29-BE29/04/201321 August 2017Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosisRelapsing multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma AGNot RecruitingFemale: yes
Male: yes
380Phase 2Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden
595NCT03198351April 25, 201323 July 2018An Observational Study on Teriflunomide-exposed PregnanciesTeriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy ProjectMultiple SclerosisDrug: Teriflunomide (HMR1726)SanofiRecruiting16 YearsN/AFemale325Phase 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
596EUCTR2012-004436-36-DK19/04/20137 November 2016Effect of rituximab in secondary progressive multiple sclerosisA prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosisMultiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MabThera (Rituximab)
Product Name: MabThera
Pharmaceutical Form: Injection
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Odense University HospitalNot RecruitingFemale: yes
Male: yes
15Phase 2Denmark
597EUCTR2012-005507-40-IT15/04/201330 June 2014Study to provide access to fingolimod to Multiple Sclerosis patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drugAn open-label, single arm study to provide access to fingolimod to MS patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drugMultiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
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-
NOVARTIS FARMA S.p.ANot RecruitingFemale: yes
Male: yes
Phase 3bItaly
598EUCTR2012-005113-39-AT08/04/201322 April 2013Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve.A Randomized, Placebo-Controlled, Double-Blind, Phase IIa Study of Amiloride in the Treatment of Acute Autoimmune Optic Neuritis - Amiloride Hydrochlorothiazide in acute autoimmune optic neuritisOptic neuritis is among the most common first symptoms of multiple sclerosis leading to significant atrophy of the optic nerve within a short period of time, thus reflecting neurodegneration.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Amilostad HCT
Product Name: Amilostad HCT tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: AMILORIDE HYDROCHLORIDE, 2 H2O
Other descriptive name: Amiloride Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.68-
INN or Proposed INN: hydrochlorothiazide
Other descriptive name: HYDROCHLOROTHIAZIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Universitätsklinik für Neurologie, Medizinische Universität WienAuthorisedFemale: yes
Male: yes
Phase 2aAustria
599EUCTR2012-005082-13-IT02/04/20136 January 2015A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple SclerosisA Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Code: AN100226, BG00002
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 Idec Research LimitedNot RecruitingFemale: yes
Male: yes
12Phase 1Italy
600NCT01738347April 201316 December 2017Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the Imaging Protocol of GEH120714 (18F) Injection, a Marker of Microglial Activation, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS)Relapsing-remitting Multiple Sclerosis (rrMS)Drug: Arm 1 - GEH120714 (18F) InjectionGE HealthcareCentre for Probe Development and CommercializationNot recruiting20 Years50 YearsAll30Phase 1Canada;United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
601NCT01808885April 20135 December 2016Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.Relapsing Remitting Multiple SclerosisDrug: olesoxime (TRO19622);Drug: placeboHoffmann-La RocheHôpital de la Timone;SGS S.A.;STRAGEN ServicesNot recruiting18 YearsN/ABoth44Phase 1France
602NCT01816100April 201321 December 2015The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis PatientsThe Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients: A Multimodal Neuroimaging InvestigationMultiple SclerosisOther: specifically design 6 month resistance training program;Behavioral: 6 months weight resistance and balance programUniversity of NebraskaBiogenNot recruiting19 Years65 YearsBoth6N/AUnited States
603NCT01844232April 201325 May 2015One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With SpasticityA One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With SpasticityMultiple Sclerosis;SpasticityDrug: arbaclofenOsmotica Pharmaceutical Corp.Not recruiting18 Years70 YearsBoth150Phase 3United States;Russian Federation;Ukraine
604NCT01888354April 201319 February 2015Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS ExacerbationsPilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ) Versus ACTHar Gel Five Days SQ for the Treatment of MS ExacerbationsMultiple Sclerosis (MS)Drug: H.P. Acthar Gel (repository corticotropin injection)The University of Texas Health Science Center, HoustonNot recruiting18 Years55 YearsBoth25Phase 4United States
605NCT01838668March 28, 20133 December 2018An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: Placebo;Drug: dimethyl fumarateBiogenNot recruiting18 Years55 YearsAll225Phase 3Czechia;Japan;Korea, Republic of;Poland;Taiwan;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
606NCT01808482March 13, 201316 December 2017A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)A First Time in Human Study Exploring Preliminary Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Part A: 100 mg/mL GSK2618960;Drug: Part A: matching placebo;Drug: Part B: Dose of GSK2618960 decided from Part A;Drug: Part B: matching placebo;Drug: Part C: Dose of GSK2618960 decided from Part A and BGlaxoSmithKlineNot recruiting18 Years55 YearsMale16Phase 1United Kingdom
607EUCTR2011-002959-34-DK11/03/201317 October 2016RETRAP - A study of the effect of combination of resistance training and prolonged-release fampridine on muscle strength in the legs, walking capacity and quality of life in multiple sclerosis patients.RETRAP - A double blind, randomized, placebo controlled study of the effect of the combination of resistance training and prolonged release fampridine on muscle strength in the lower extremities, walking capacity and quality of life in relapsing remitting multiple sclerosis - RETRAPMultiple sclerosis
MedDRA version: 15.1 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: Fampyra
Product Name: Fampyra
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sønderjylland Hospital, department of neurologyNot RecruitingFemale: yes
Male: yes
125Phase 4Denmark
608EUCTR2012-002639-27-GB11/03/20135 August 2013A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A 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 sclerosis (RRMS)
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: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-
Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.2-
Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Mitsubishi Tanabe Pharma Corporation (MTPC)AuthorisedFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Switzerland;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
609NCT01714089March 201318 April 2016Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple SclerosisA Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: RNS60 125 ml;Drug: RNS60 250 ml;Drug: Interferon beta 1aRevalesio CorporationNot recruiting18 Years50 YearsBoth0Phase 2United States
610NCT01768039March 201319 February 2015Vitamine D in Multiple SclerosisRandomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple SclerosisMultiple SclerosisDrug: Vitamin D;Drug: PlaceboMazandaran University of Medical SciencesNot recruiting18 Years50 YearsBoth240Phase 3Iran, Islamic Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
611NCT01803867March 20139 March 2015An Intravenous Infusion Study of rHIgM22 in Patients With Multiple SclerosisA Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS)Multiple SclerosisDrug: rHIgM22Acorda TherapeuticsPRA Health SciencesNot recruiting18 Years70 YearsBoth72Phase 1United States
612NCT01834586March 201311 June 2018Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis MedicationsPilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)Multiple SclerosisDrug: Anesthetic Topical Adhesive SyneraBrown, Theodore R., M.D., MPHNot recruiting18 YearsN/AAll30Phase 4United States
613NCT01791244February 28, 201316 December 2017A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ DeviceA Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program (MinSupport Plus) on Health Related Quality of Life (HRQoL) and Adherence in Patients With Relapsing Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart DeviceMultiple Sclerosis;Relapsing-RemittingDrug: Rebif®Merck KGaANot recruiting18 YearsN/AAll93Phase 4Germany;Sweden
614EUCTR2011-000985-36-ES22/02/20132 June 2014Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with SativexStudy on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with SativexSpasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex
MedDRA version: 14.1 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: SATIVEX
Product Name: sativex
Product Code: N02BG10
Pharmaceutical Form: Oromucosal solution
INN or Proposed INN: pending
CAS Number: 13956-29-1
Current Sponsor code: pending
Other descriptive name: CANNABIDIOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.7-
JOSE MANUEL GARCIA DOMINGUEZNot RecruitingFemale: yes
Male: yes
Spain
615NCT01707992February 20, 201311 June 2018The Efficacy, Safety, and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Laquinimod;Drug: Matching PlaceboTeva Branded Pharmaceutical Products, R&D Inc.Not recruiting18 Years55 YearsAll2199Phase 3United States;Austria;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Macedonia, The Former Yugoslav Republic of;Moldova, Republic of;Montenegro;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom;Belgium;Czech Republic;Kazakhstan;Mexico;Portugal
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
616NCT01797965February 15, 20133 December 2018Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301Relapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: BIIB019 (Daclizumab)BiogenAbbVieNot recruiting18 YearsN/AAll1501Phase 3United States;Argentina;Australia;Brazil;Canada;Czechia;Denmark;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;China;Czech Republic;Finland
617EUCTR2012-000411-91-DE13/02/20134 December 2018Monitoring natural killer cells in multiple sclerosis patients treated with fingolimodMonitoring natural killer cells in multiple sclerosis patients treated with fingolimod: a monocentric, prospective, one year, baseline-to-treatment, open-label, single group pilot trial - NKZellen-Version1.0relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Gilenya®
Product Name: Gilenya®
Product Code: Gilenya®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-55-9
Current Sponsor code: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,5-
Charité - Universitätsmedizin BerlinNot RecruitingFemale: yes
Male: yes
40Phase 4Germany
618NCT01730547February 201319 February 2015Mesenchymal Stem Cells for Multiple SclerosisPhase 1/2 Clinical Trial With Autologous Mesenchymal Stem Cells for the Therapy of Multiple SclerosisMultiple SclerosisBiological: Autologous mesenchymal stem cellsKarolinska InstitutetRecruiting18 Years50 YearsBoth15Phase 1/Phase 2Sweden
619NCT01772199February 201322 August 2016Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple SclerosisProof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GSK239512;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years50 YearsBoth131Phase 2Bulgaria;Canada;Czech Republic;Germany;Spain;Sweden;Ukraine;United Kingdom
620NCT01802489February 201311 June 2018Amiloride Clinical Trial In Optic NeuritisA Double Blind Randomised Control Trial on Neuroprotection of Amiloride in Optic NeuritisOptic Neuritis;Multiple SclerosisDrug: Amiloride;Drug: PlaceboUniversity of OxfordMultiple Sclerosis Society of Great Britain and Northern IrelandNot recruiting18 Years55 YearsAll46Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
621NCT01848327February 20135 February 2018Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple SclerosisA Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.Relapsing Remitting MS;Secondary Progressive MS;Primary Progressive MSDietary Supplement: Caprylic Triglyceride;Dietary Supplement: PlaceboUniversity of MiamiNational Multiple Sclerosis Society;Accera, Inc.Not recruiting18 Years59 YearsAll124N/AUnited States
622NCT02040116February 201316 December 2017Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune DiseasesStudy Evaluating Rapid Infusion Rituximab in Patients With Autoimmune DiseasesMultiple SclerosisDrug: Rituximab InfusionWake Forest University Health SciencesNot recruiting18 Years80 YearsAll19Phase 4United States
623EUCTR2012-003627-38-SE30/01/201310 July 2015Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple SclerosisProof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple Sclerosis
MedDRA version: 16.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: GSK2395612
Pharmaceutical Form: Tablet
INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone
CAS Number: 720691-69-0
Current Sponsor code: GSK239512
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: GSK239512
Pharmaceutical Form: Tablet
INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone
CAS Number: 720691-69-0
Current Sponsor code: GSK239512
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: GSK239512
Pharmaceutical Form: Tablet
INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone
CAS Number: 720691-69-0
Current Sponsor code: GSK239512
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: GSK239512
Pharmaceutical Form: Tablet
INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone
CAS Number: 720691-69-0
Current Sponsor code: GSK239512
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes
114Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden
624EUCTR2012-004183-21-GB25/01/201330 April 2019Melatonin for Nocturia in patients with Multiple SclerosisA randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension study - Melatonin for Nocturia in MSNocturia; Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Circadin
Product Name: Circadin
Product Code: N/A
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Circadin ( INN= Melatonin)
CAS Number: 73-31-4
Current Sponsor code: N/A
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
North Bristol NHS TrustNot Recruiting Female: yes
Male: yes
80Phase 2United Kingdom
625EUCTR2012-004847-61-GB16/01/20134 August 2015INSPIRE: Raltegravir (Isentress) Pilot Study in Relapsing MSA phase II baseline versus treatment study to determine the efficacy of raltegravir (ISENTRESS) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI - INSPIRE (Isentress Pilot Study in Relapsing MS)Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: ISENTRESS
Product Name: raltegravir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lactose monohydrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 26.06-
Queen Mary University of LondonNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
626EUCTR2012-004602-97-ES11/01/201311 June 2018?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial??Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial? - VITADEMRELAPSING-REMITING MULTIPLE SCLEROSIS
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM)
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 4000-
Pharmaceutical form of the placebo: Oral drops, solution
Route of administration of the placebo: Oral use
Javier Olascoaga UrtazaNot RecruitingFemale: yes
Male: yes
100Phase 2Spain
627NCT01802931January 7, 201316 December 2017GSK239512 DDI StudyAn Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK239512Multiple SclerosisDrug: GSK239512;Drug: ketoconazoleGlaxoSmithKlineNot recruiting18 Years45 YearsMale22Phase 1Australia
628EUCTR2012-005076-34-BE03/01/20137 October 2014Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters. A cross-over, double-blinded, placebo-controlled study.Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters. A cross-over, double-blinded, placebo-controlled study.Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Fampyra
Product Name: Fampridine
Product Code: BIIB041
Pharmaceutical Form: Prolonged-release tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Cliniques Universitaires Saint-Luc, NeurologieAuthorisedFemale: yes
Male: yes
Belgium
629NCT01606215January 201326 August 2019Stem Cells in Rapidly Evolving Active Multiple SclerosisStem Cells in Rapidly Evolving Active Multiple SclerosisMultiple SclerosisDrug: Mesenchymal stem cells;Drug: PlaceboImperial College LondonNot recruiting18 Years50 YearsAll21Phase 1/Phase 2United Kingdom
630NCT01742052January 201326 September 2016Dose-finding Study of MT-1303A Phase II, Multicentre, Randomised, Double-blind,Parallel Group, Placebo-controlled, Dose-finding Study to Evaluate the Safety and Efficacy of Three Different Oral Doses of MT-1303 Administered for a Period of 24 Weeks in Subjects With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: MT-1303-Low;Drug: MT-1303-Middle;Drug: MT-1303-High;Drug: PlaceboMitsubishi Tanabe Pharma CorporationNot recruiting18 Years60 YearsBoth415Phase 2Belgium;Bulgaria;Canada;Croatia;Czech Republic;Finland;Germany;Hungary;Italy;Lithuania;Poland;Russian Federation;Serbia;Spain;Switzerland;Turkey;Ukraine;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
631NCT01753375January 201319 February 2015Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple SclerosisRole of Vitamin D on the Relapse Rate of Multiple SclerosisMultiple SclerosisDietary Supplement: Vitamin D3;Dietary Supplement: PlaceboAlJohara M AlQuaiz, M.D.Not recruiting18 Years55 YearsBoth200Phase 2Saudi Arabia
632NCT01755871January 201320 June 2016Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple SclerosisThe Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: FingolimodHeinrich-Heine University, DuesseldorfNovartis PharmaceuticalsNot recruiting18 Years65 YearsBoth8Phase 4Germany
633NCT01759602January 201319 October 2017C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica ExacerbationPhase 1b Study of C1-esterase Inhibitor (Cinryze) With Standard of Care for Acute Treatment of Neuromyelitis Optica ExacerbationsNeuromyelitis OpticaDrug: C1-esterase inhibitor (Cinryze)Michael LevyViroPharmaNot recruiting18 Years65 YearsAll10Phase 1United States
634NCT01779934January 201314 March 2016OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple SclerosisOpen-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisDrug: FTY720Novartis PharmaceuticalsNot recruiting28 YearsN/ABoth579Phase 3United States;Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom
635NCT01665144December 20, 201230 September 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 Sclerosis Followed by Extended Treatment With Open-label BAF312.Secondary Progressive Multiple SclerosisDrug: BAF312;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 Years60 YearsAll1652Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;China;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Latvia;Lithuania;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Egypt
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
636EUCTR2012-003056-36-SK10/12/201228 February 2019Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPANDSecondary progressive multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Siponimod 2 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Siponimod 1 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Siponimod 0.5 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Siponimod 0.25 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
Novartis Pharma Services AGNot Recruiting Female: yes
Male: yes
1530Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden
637EUCTR2012-000721-53-SE07/12/201224 September 2018An extension trial of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosisITT-PMS Extension An extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis - ITT-PMS ExtSecondary progressive multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera
Product Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Dept of Neurology, Umeå University Hospital, Umeå, SwedenNot RecruitingFemale: yes
Male: yes
30Phase 2Sweden
638NCT01766063December 6, 201226 February 2018Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on BetaferonBETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS PatientsMultiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY 86-5046)BayerNot recruiting18 YearsN/AAll138N/AGermany
639NCT01272128December 201226 October 2015Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL StudyA Multicenter, Prospective Non-interventional Study to Evaluate the Quality of Life in Belgian Patients With CIS or RRMS in Whom Interferon Beta-1a IM Treatment Has Been InitiatedMultiple SclerosisDrug: Interferon beta-1aBiogenNot recruiting18 YearsN/ABoth100N/ABelgium;United States
640NCT01720849December 20123 August 2015Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple SclerosisMultiple Sclerosis;EDSS 4-7Drug: FampyraVestre Viken Hospital TrustRecruiting18 YearsN/ABoth50N/ANorway
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
641NCT01764737December 201219 February 2015Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MSA Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of Intravenous VX15/2503 In Patients With Multiple SclerosisMultiple SclerosisDrug: VX15/2503;Drug: PlaceboVaccinex Inc.PRA Health SciencesNot recruiting18 Years60 YearsBoth50Phase 1United States
642NCT01879202December 201225 May 2015Methylphenidate as Treatment Option of Fatigue in Multiple SclerosisMethylphenidate Modified-release as Treatment of MS-associated Fatigue. A Single-center Randomized Double-blind Placebo-controlled Study.Multiple Sclerosis;FatigueDrug: Methylphenidate modified release;Drug: MaltodextrinMedical University of ViennaRecruiting18 YearsN/ABoth96Phase 2Austria
643EUCTR2012-000835-18-SE07/11/201221 September 2015A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMSOpen-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosisPrimary progressive multiple sclerosis.
MedDRA version: 16.0 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359- 56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
700United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
644EUCTR2012-001965-34-ES07/11/201217 May 2016Study to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.Multiple sclerosis
MedDRA version: 15.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Urbason 40 mg
Pharmaceutical Form: Capsule
CAS Number: 03/03/2375
Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 625-1250
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Servicio de Neurología, HU. Germans Trias i PujolNot RecruitingFemale: yes
Male: yes
Phase 4Spain
645NCT01728922November 6, 201216 December 2017Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated SyndromeDose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome and Healthy Control Participants. An Exploratory Double Blind Placebo Randomised Controlled Study.Clinically Isolated Syndrome;Multiple SclerosisDietary Supplement: 5000IU vitamin D;Dietary Supplement: 10000IU vitamin D;Other: PlaceboUniversity College DublinUniversity of Dublin, Trinity College;St Vincent's University Hospital, IrelandNot recruiting18 Years55 YearsAll64Phase 1/Phase 2Ireland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
646NCT01679041November 201219 February 2015High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior TreatmentA Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of TherapyMultiple SclerosisDrug: Alemtuzumab;Drug: Fludarabine;Drug: CyclophosphamideSeah Lim M.D.Not recruiting18 Years60 YearsBoth1Phase 2United States
647NCT01743651November 201219 February 2015Efficacy Study of Arbaclofen to Treat Spasticity in Multiple SclerosisA Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple SclerosisSpasticity;Multiple SclerosisDrug: arbaclofen;Drug: baclofen;Drug: PlaceboOsmotica Pharmaceutical Corp.Not recruiting18 Years65 YearsBoth353Phase 3United States;Russian Federation;Ukraine
648NCT01744444November 201219 February 2015Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple SclerosisPendular Nystagmus Patients With Multiple SclerosisDrug: Memantine;Drug: GabapentinHospices Civils de LyonNot recruiting18 YearsN/ABoth10Phase 2France
649NCT01767493November 201219 February 2015Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS PatientsAn Open-label, Non-randomized Study to Evaluate the Feasibility of [18F]Florbetapir Positron Emission Tomography (PET) for Assessment of Demyelination in Patients With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: [18F]Florbetapir and PET imagingInstitute for Neurodegenerative DisordersBiogen IdecRecruiting18 Years60 YearsBoth18N/AUnited States
650NCT02137707November 201219 November 2018Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With GilenyaAn Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 YearsMultiple Sclerosis-Relapsing-RemittingDrug: GilenyaMcGill UniversityNovartisNot recruiting18 Years65 YearsAll135Phase 4Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
651NCT02775110November 201223 May 2016Natalizumab Temporary Discontinuation StudyNatalizumab Temporary Discontinuation StudyMultiple SclerosisOther: Natalizumab discontinuationUniversity at BuffaloNot recruiting18 Years65 YearsBoth50Phase 4United States
652EUCTR2012-003056-36-HU31/10/201219 November 2018Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosisA 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 sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Siponimod 2 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Siponimod 1 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Siponimod 0.5 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Siponimod 0.25 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
1530Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden
653EUCTR2012-002470-31-GB29/10/20124 August 2015A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosisRelapsing-Remitting Multiple Sclerosis
MedDRA version: 15.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.2-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Mitsubishi Tanabe Pharma Corporation (MTPC)Not RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Switzerland;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
654EUCTR2011-004787-30-DE26/10/201230 May 2016Modification of the visual outcome after optic neuritis in CIS or MS by Gilenya®Modification of the visual outcome after optic neuritis in CIS or MS by Gilenya® - MOVINGMultiple sclerosis or clinically isolated syndrom;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Gilenya®
Product Name: Gilenya®
Product Code: Gilenya®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-55-9
Current Sponsor code: Gilenya
Other descriptive name: FINGOLIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,5-
Trade Name: Extavia®
Product Name: Extavia®
Product Code: Extavia®
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Interferon beta 1B
CAS Number: 145155-23-3
Current Sponsor code: Extavia
Other descriptive name: INTERFERON BETA-1B
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Charite Universitaetsmedizin BerlinNot RecruitingFemale: yes
Male: yes
Phase 3Germany
655EUCTR2012-002357-35-GB23/10/201230 April 2019Bone marrow stem cells to treat multiple sclerosisStem cells in Rapidly Evolving Active Multiple Sclerosis (STREAMS) - Stem cells in Rapidly Evolving Active Multiple Sclerosis (STREAMS)Multiple Sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Autologous Mesenchymal Cell Product
Pharmaceutical Form: Suspension for injection in cartridge
Pharmaceutical form of the placebo: Suspension for infusion
Route of administration of the placebo: Intravenous use
Imperial College LondonNot Recruiting Female: yes
Male: yes
13Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
656EUCTR2012-003418-15-AT23/10/201219 November 2012Methylphenidate modified release as treatment of MS-associated fatigue.Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial.Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIV and parkinson´s disease, data on its efficacy in MS are not available. ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Ritalin LA 20mg capsules
Product Name: Methylphenidate modified release 20 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Ritalin LA 30mg capsules
Product Name: Methylphenidate modified release 30 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Trade Name: Ritalin LA 40mg capsules
Product Name: Methylphenidate modified release 40 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Medizinische Universität WienAuthorisedFemale: yes
Male: yes
Austria
657EUCTR2012-002637-11-DE15/10/201211 March 2013A 6 months, multicenter study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosisA 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis - STAYTreatment statisfaction in patients with relapsing remitting Multiple Sclerosis
MedDRA version: 15.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
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-
Novartis Pharma GmbHNot RecruitingFemale: yes
Male: yes
Germany
658NCT01578330October 201219 October 2017A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720A 12 -Month, Open-label, Multi-center Pilot Study to Explore the Health Outcomes of FTY720 in RRMS Patients Who Have Previously Been Treated With Other Disease Modifying Therapies (DMT)- FineMultiple Sclerosis;Relapsing-RemittingDrug: FingolimodNovartis PharmaceuticalsNot recruiting18 Years65 YearsAll42Phase 4Turkey
659NCT01698086October 201211 February 2019Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most? (MSVR3trial)Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most?Multiple Sclerosis;Balance;Fatigue;Eye MovementOther: Vestibular rehabilitation: balance and eye movement exercisesUniversity of Colorado, DenverNational Multiple Sclerosis SocietyNot recruiting18 Years60 YearsAll88N/AUnited States
660NCT01895439October 201216 December 2017Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple SclerosisPhase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional TreatmentMultiple SclerosisBiological: Autologous Mesenchymal Stem CellsUniversity of JordanNot recruiting18 Years65 YearsAll13Phase 1/Phase 2Jordan
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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Target_
size
PhaseCountries
661EUCTR2011-001437-16-DE19/09/201225 September 2012A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosisA 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis -multiple sclerosis
MedDRA version: 15.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
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-
Trade Name: Extavia
Pharmaceutical Form: Powder and solvent for solution for 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: Tysabri
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: 20-
Trade Name: Copaxone
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: Avonex
Pharmaceutical Form: Powder and solvent for solution for 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-
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
420Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Czech Republic;United Kingdom;Canada;Denmark;Spain;United States;Poland
662EUCTR2012-000635-68-IE19/09/201221 August 2017An initial, short-duration study of vitamin D versus an inactive therapy on the ability of the human immune system to counteract the effects of Multiple Sclerosis on the brain and the effects of vitamin D on the immune system in healthy individuals.Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome or early multiple sclerosis and healthy control participants. An exploratory randomised double blind placebo controlled study - N/AMultiple Sclerosis
MedDRA version: 14.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Vigantol
Product Name: N/A
Product Code: N/A
Pharmaceutical Form: Oral drops, solution
Pharmaceutical form of the placebo: Oral drops, solution
Route of administration of the placebo: Oral use
University College DublinNot RecruitingFemale: yes
Male: yes
Phase 2Ireland
663NCT01628393September 18, 201217 June 2019Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients (Radiance Study)A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis PatientsRelapsing Multiple SclerosisDrug: RPC1063;Drug: placeboCelgeneNot recruiting18 Years55 YearsAll258Phase 2/Phase 3United States;Belgium;Bulgaria;Georgia;Greece;Hungary;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine
664NCT01413243September 201217 May 2016Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated SyndromeTrichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome - A Monocentric, Prospective, Randomized, Double-blind and Placebo-controlled Phase 2 TrialMultiple SclerosisDrug: Trichuris suis ovaCharite University, Berlin, GermanyNot recruiting18 Years65 YearsBoth50Phase 2Germany
665NCT01624714September 201219 February 2015Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced SubjectsPhase I Trial Monitoring Efficacy and Safety in Treatment of Alemtuzumab Naive Subjects and Data Collecting and Monitoring of Alemtuzumab Experienced Subjects With Refractory Multiple SclerosisMultiple SclerosisDrug: Alemtuzumab;Drug: Alemtuzumab immunotherapySamuel Forrester Hunter, MD, PhDNot recruiting18 Years75 YearsBoth60Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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Status
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PhaseCountries
666NCT01667484September 201225 May 2015Adderall XR and Processing Speed in Multiple Sclerosis (MS)Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?Impaired Processing Speed;Cognitive Impairment;Multiple SclerosisDrug: Adderall XR 5mg;Drug: Adderall XR 10 mg;Drug: PlaceboLondon Health Sciences CentreNot recruiting18 Years59 YearsBoth70Phase 2/Phase 3Canada
667NCT01667497September 201214 September 2015Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients?Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? A Cross Over StudyCognitive FatigueDrug: Fampridine SR;Drug: PlaceboLondon Health Sciences CentreNot recruiting18 Years64 YearsBoth60Phase 2/Phase 3Canada
668NCT01701856September 201219 February 2015Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple SclerosisNatalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV StudyRelapsing-remitting Multiple SclerosisDrug: Interferon beta-1bClaudio GobbiBayerNot recruiting18 Years70 YearsBoth5Phase 4Switzerland
669NCT01706055September 201216 December 2017Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®Multiple SclerosisBiological: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/AAll629N/APoland
670NCT02442570September 20127 September 2015A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple SclerosisA Phase IIa, Randomized, Double-blind, Placebo-controlled, Exploratory, Dose-ranging Study to Evaluate the Safety, Effectiveness and Pharmacokinetics of Three Courses of DC-TAB Treatment in Patients With Multiple SclerosisMultiple SclerosisBiological: recombinant human alpha B-crystallin;Other: Placebo comparatorDelta Crystallon BVNot recruiting18 Years55 YearsBoth32Phase 2Bulgaria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
671NCT02463318September 201216 December 2017The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy SubjectsMultiple Sclerosis;Oxidative StressDrug: Melatonin;Other: Hydrogen peroxideTehran University of Medical SciencesNot recruiting20 Years40 YearsFemale34N/AIran, Islamic Republic of
672NCT01633112August 9, 201215 October 2018MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus CopaxoneA 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple Sclerosis (RRMS)Drug: fingolimod;Drug: copaxoneNovartis PharmaceuticalsNot recruiting18 Years65 YearsAll1064Phase 4United States;Argentina;Brazil;Canada;Chile;Mexico;Puerto Rico
673NCT01582126August 20127 April 2015Group Balance Training for People With Multiple SclerosisGroup Balance Training for People With Multiple SclerosisMultiple SclerosisOther: Group balance trainingÖrebro County CouncilUppsala-Örebro Regional Research Council;Norrbacka-Eugenia FoundationNot recruiting18 YearsN/ABoth87N/ASweden
674NCT01597297August 201216 December 2017Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects With Multiple SclerosisMultiple SclerosisDrug: BIIB041 (PR Fampridine);Other: PlaceboBiogenNot recruiting18 Years70 YearsAll132Phase 2Belgium;Canada;Italy;Netherlands;Sweden;United Kingdom
675NCT01684761August 201216 December 2017Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple SclerosisA Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple SclerosisAutoimmune Diseases of the Nervous System;Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Disease Progression;Brain AtrophyBiological: Tcelna;Biological: PlaceboOpexa Therapeutics, Inc.Not recruiting18 Years60 YearsAll183Phase 2United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
676EUCTR2011-005475-16-GB25/07/201231 July 2012A Phase 1/2 study to test how effective different doses of MEDI-551 is for treating subjects with Relapsing-Remitting Multiple SclerosisA Phase 1/2 Randomized, Dose-finding Study of MEDI-551 in Subjects with Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: MEDI-551
Product Code: MEDI-551
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: MEDI-551
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Avonex
Product Name: Avonex
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: interferon beta-1a
CAS Number: 220581-49-7
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 60-
MedImmune LLCAuthorisedFemale: yes
Male: yes
512Phase 1/2Hungary;Germany;Turkey;Switzerland;Netherlands;France;Ireland;Italy;Austria;Sweden;Israel;Russian Federation;United Kingdom;Czech Republic;Ukraine;Canada;Denmark;Spain;United States;Poland
677NCT01639300July 201226 February 2018Safety Study of GNbAC1 in Multiple Sclerosis PatientsRandomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1Multiple SclerosisBiological: GNbAC1;Biological: GNbAC1 placeboGeNeuro Innovation SASNot recruiting18 Years65 YearsAll10Phase 2Switzerland
678NCT01854957July 201219 February 2015MEsenchymal StEm Cells for Multiple SclerosisMEsenchymal StEm Cells for Multiple Sclerosis (MESEMS) Phase I-II Clinical Trial With Autologous Mesenchymal Stem Cells (MSCs) for the Therapy of Multiple SclerosisMultiple SclerosisBiological: Autologous Mesenchymal Stem CellsAntonio UccelliAzienda Ospedaliera Universitaria Integrata Verona;Ospedale San RaffaeleRecruiting18 Years50 YearsBoth20Phase 1/Phase 2Italy
679NCT01585298June 29, 201216 December 2017STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: FTY720Novartis PharmaceuticalsNot recruiting18 YearsN/AAll6996Phase 4Germany
680JPRN-UMIN0000094212012/06/282 April 2019Efficacy and safety of rituximab for intractable immunogenic neurological disorder in childrenneuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS)administration of rituximabDepartment of Pediatrics, Kobe Universtiy Graduate School of MedicineRecruitingNot applicable18years-oldMale and Female10Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
681EUCTR2012-000653-32-DE27/06/20122 October 2017A study to explore heart function during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosisA 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START) - STARTConduction abnormalities in patients with relapsing-remitting multiple sclerosis
MedDRA version: 18.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
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-
Novartis Pharma GmbHNot RecruitingFemale: yes
Male: yes
Phase 4Germany
682EUCTR2012-000518-13-DK21/06/20129 January 2017Own mesenchymal stem cells for multiple sclerosis patientsImmunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study - COMSCIMSMultiple sclerosis
MedDRA version: 18.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mesenchymal stem/stromal cells
Product Name: Mesenchymal stem cells (MSCs)
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use
Prof. Per Soelberg SørensenNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
683NCT01623596June 8, 201215 April 2019Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Disease Modifying therapyNovartis PharmaceuticalsNot recruiting18 Years65 YearsAll881Phase 4United States;Puerto Rico
684JPRN-jRCTs03118015204/06/20127 October 2019Tocilizumab in patients with neuromyelitis opticaThe safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter study - Tocilizumab in patients with neuromyelitis opticaNeuromyelitis optica;D009471Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months.Takashi YamamuraNot Recruiting>= 20age old<= 65age oldBoth20N/Anone
685NCT01600716June 201219 October 2017Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)Urinary Incontinence;Multiple Sclerosis;Neurogenic BladderBiological: OnabotulinumtoxinA;Drug: Placebo (Normal Saline)AllerganNot recruiting18 YearsN/AAll144Phase 3United States;Belgium;Canada;Czech Republic;France;Poland;Portugal;Russian Federation
No.TrialIDDate_
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686NCT01656148June 20123 September 2018FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of FampyraFampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of FampyraMultiple SclerosisDrug: Fampridine-SRUniversity of Southern DenmarkRegion of Southern Denmark;BiogenNot recruiting18 Years60 YearsAll108Phase 4Denmark
687NCT01712945June 201213 May 2019Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple SclerosisKeratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple SclerosisMultiple SclerosisDrug: Palifermin;Drug: AlemtuzumabCambridge University Hospitals NHS Foundation TrustNot recruiting18 Months50 YearsAll40Phase 1/Phase 2United Kingdom
688EUCTR2012-000287-17-IT21/05/201210 February 2014functional MRI study to evaluate improvement of hand performance after combined motor exercise and aminopiridine assumptionPROMOTION OF FUNCTIONAL RESTORATION THROUGH PHARMACOLOGICAL MODULATION OF BRAIN PLASTICITY WITH AMINOPYRIDINE IN PATIENTS WITH MULTIPLE SCLEROSIS STUDIED BY FUNCTIONAL MRIPatients with MS, without relevant medical conditions, with right upper limb impairment assessed by a hand dexterity test will be included.Patients will be in a non-active phase of the disease and under a stable pharmacological treatment.They will not be included if they have received physiotherapy in the previous few months. Healthy volunteers will be recruited if they have no relevant medical condition and no contraindication to perform a MRI scan.
MedDRA version: 14.1 Level: LLT Classification code 10028053 Term: MS System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FAMPYRA
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use
FONDAZIONE SANTA LUCIAAuthorisedFemale: yes
Male: yes
Italy
689EUCTR2011-004475-36-BG19/05/201214 March 2016A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosisA Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosisRelapsing multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DC-TAB
Product Code: DC-TAB
Pharmaceutical Form: Solution for injection
Current Sponsor code: recombinant human CRYAB
Other descriptive name: recombinant human alpha B-crystallin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Delta Crystallon B.V.Not RecruitingFemale: yes
Male: yes
Phase 2aBulgaria
690EUCTR2011-005550-57-LV15/05/201225 March 2013A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW studyRelapsing-remitting Multiple sclerosis (RRMS)
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 20mg/0.5ml glatiramer acetate
Product Code: 20mg/0.5ml GA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Current Sponsor code: 20 mg/0.5 ml GA
Other descriptive name: glatiramer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Teva Pharmaceutical Industries Ltd.Not RecruitingFemale: yes
Male: yes
1400Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
691JPRN-UMIN0000078662012/05/012 April 2019The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Studyneuromyelitis opticaTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years.Department of Immunology, National Institute of Neuroscience, NCNPDepartment of Neurology, Kinki University Faculty of MediceineNot Recruiting20years-old65years-oldMale and Female15Not applicableJapan
692NCT01641120May 201219 October 2017Assessing Tolerability of Avonex Intramuscular InjectionsAssessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge NeedleMultiple SclerosisDrug: AvonexSaint Francis CareBiogenNot recruiting18 Years65 YearsAll20N/AUnited States
693NCT01718678May 201219 February 2015Effect of Melatonin on Multiple Sclerosis Related FatigueStudy of Melatonin in Treatment of Fatigue in Multiple SclerosisFatigueDrug: Melatonin;Drug: PlaceboIsfahan University of Medical SciencesNot recruiting18 Years55 YearsBoth44Phase 2Iran, Islamic Republic of
694NCT02142205May 201219 February 2015Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®).Relapsing-Remitting Multiple SclerosisBiological: BG00002Biogen IdecBiogen Idec International GmbHNot recruiting18 Years60 YearsBoth100Phase 4Russian Federation
695NCT01491100April 30, 201211 June 2018Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple SclerosisStudy Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting12 Years70 YearsAll1085Phase 4Albania;Algeria;Argentina;Belgium;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Kazakhstan;Netherlands;Portugal;Saudi Arabia;Tunisia;Turkey;Bosnia and Herzegovina;Czech Republic;Jordan;Lebanon;Mexico;Poland;Syrian Arab Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
696EUCTR2011-005606-30-GB25/04/20121 May 2012Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H).Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THYThis trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab.
MedDRA version: 14.1 Level: PT Classification code 10058948 Term: Nephritis autoimmune System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1 Level: PT Classification code 10049046 Term: Autoimmune thyroiditis System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.1 Level: PT Classification code 10061664 Term: Autoimmune disorder System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1 Level: LLT Classification code 10068004 Term: Autoimmune hyperthyroidism System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.1 Level: PT Classification code 10050245 Term: Autoimmune thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kepivance
Product Name: Kepivance
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Palifermin
CAS Number: 162394-19-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: MabCampath
Product Name: Alemtuzumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Alemtuzumab
CAS Number: 216503-57-0
Other descriptive name: anti-CD52 monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Cambridge University Hospitals NHS Foundation Trust and University of CambridgeAuthorisedFemale: yes
Male: yes
86United Kingdom
697NCT01480063April 16, 201217 June 2019An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical PracticeA Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)Multiple SclerosisDrug: FampridineBiogenNot recruitingN/AN/AAll4734N/AArgentina;Canada;Czechia;France;Germany;Ireland;Israel;Lebanon;Netherlands;Norway;Portugal;Spain;United Arab Emirates;Australia;Belgium;Czech Republic;Denmark
698EUCTR2010-020337-99-NL13/04/201228 February 2019A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA IRelapsing 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: ocrelizumab 300mg /10ml
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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 8.8-22
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
F.Hoffmann-La RocheAuthorised Female: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Netherlands;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
699NCT01514370April 201212 September 2016Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1aProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW)Multiple SclerosisDrug: IFN beta 1 a + curcumin (BCM 95);Drug: IFN beta-1a + placeboMerck KGaAMerck Serono S.P.A., ItalyNot recruiting18 Years60 YearsBoth80Phase 2Italy
700NCT01538225April 201219 February 2015Neurophysiological Study of Sativex in Multiple Sclerosis (MS) SpasticityNeurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple SclerosisMultiple SclerosisDrug: Sativex®;Drug: PlaceboAlmirall, S.A.Not recruiting18 YearsN/ABoth45Phase 3Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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sponsor
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agemin
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PhaseCountries
701NCT01585766April 201229 August 2016Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple SclerosisA Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple SclerosisMultiple Sclerosis, Relapsing FormsBiological: MEDI-551 IV;Biological: MEDI-551 SC;Drug: Placebo IV;Drug: Placebo SCMedImmune LLCNot recruiting18 Years65 YearsBoth56Phase 1United States;Poland;Spain;Ukraine;Czech Republic;United Kingdom
702NCT01627938April 201219 February 2015Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in CombinationA Phase II Proof of Concept Study Evaluating the Reduction of Mitoxantrone-induced Cardiotoxicity and Neurological Outcome in the Combined Use of Mitoxantrone and Dexrazoxane (Cardioxane®) in Multiple Sclerosis (MSCardioPro)Multiple SclerosisDrug: Dexrazoxane (DRZ) plus Mitoxantrone (MX);Drug: Placebo plus Mitoxantrone (MX)PD Dr. Andrew ChanNot recruiting18 Years55 YearsBoth50Phase 2Germany
703EUCTR2011-002561-38-IE30/03/201218 April 2012Trial on the effectiveness of Fampridine medication for upper limb function in people with MS.A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis.Multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fampyra
Product Name: Fampyra
Product Code: SUB0750MIG
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use
St. Vincent's University HospitalAuthorisedFemale: yes
Male: yes
Ireland
704NCT01404117March 201219 February 2015A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and TolerabilityRelapsing Multiple SclerosisDrug: Laquinimod 0.6;Drug: Laquinimod 1.2;Other: Glatiramer Acetate or interferon-beta+ PlaceboTeva Pharmaceutical IndustriesNot recruiting18 Years55 YearsBoth0Phase 2
705NCT01436838March 201212 September 2016China Betaferon Adherence, Coping and Nurse Support StudyProspective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple SclerosisMultiple Sclerosis, Chronic ProgressiveDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 Years75 YearsBoth110N/AChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
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Inclusion_
gender
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PhaseCountries
706NCT01490502March 201215 July 2019Vitamin D Supplementation in Multiple SclerosisA Randomized Controlled Trial of Vitamin D Supplementation in Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Vitamin D3Johns Hopkins UniversityOregon Health and Science University;University of California, San Francisco;Washington University School of Medicine;Icahn School of Medicine at Mount Sinai;University of Pennsylvania;Yale University;The Cleveland Clinic;University of Rochester;Stanford University;University of Virginia;Swedish Medical Center;Anne Arundel Health System Research Institute;Columbia University;University of Massachusetts, Worcester;Dignity HealthNot recruiting18 Years50 YearsAll172Phase 3United States
707NCT01576354March 201214 December 2015Characterization of the Effects of Prolonged-release Fampridine on Ambulatory Function in Patients With Multiple SclerosisA Phase IIb, Double-blind, Randomized, Mono-center, Placebo-controlled Study With Crossover Design Characterizing the Effects of Prolonged-release Fampridine Treatment on Ambulatory Function in Patients With Multiple Sclerosis Using Detailed Gait Analysis Based on Kinematic and Kinetic ParametersMultiple SclerosisDrug: Prolonged-release Fampridine;Drug: PlaceboUniversity of ZurichNot recruiting18 Years65 YearsBoth70Phase 2Switzerland
708NCT01591551March 201219 February 2015NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or SleepinessNAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or SleepinessMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab (Tysabri)Cornerstone Health Care, PABiogen IdecNot recruiting18 Years65 YearsBoth37Phase 4United States
709EUCTR2011-006043-30-NL27/02/201225 September 2012Study to evaluate the effect of oral BAF312 on a monophasic oral contraceptive in healthy female volunteersAn open-label, multiple-dose, two-treatment period study to evaluate the effect of oral BAF312 on the pharmacokinetices and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteers -healthy volunteers (Multiple sclerosis is the intended indication for BAF312)
;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BAF312 0,25 mg tablet
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Product Name: BAF312 1 mg tablet
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: BAF312 4 mg tablet
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Trade Name: Microgynon
Product Name: Microgynon
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
CAS Number: 797-63-7
Other descriptive name: LEVONORGESTREL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.15-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: no
24Netherlands
710EUCTR2010-023210-31-DE24/02/201230 June 2014The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSISNEUROGENIC DETRUSOR OVERACTIVITY
MedDRA version: 15.1 Level: LLT Classification code 10012547 Term: Detrusor hyperreflexia System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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
Other descriptive name: BOTULINUM TOXIN TYPE A
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: Intramuscular use
Ipsen InnovationNot RecruitingFemale: yes
Male: yes
42Phase 2ACzech Republic;Lithuania;Austria;Germany;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
711EUCTR2011-006151-10-DK15/02/201214 April 2014FAME - a study of the effect of Fampyra on muscle strength in the lower extremities, walking capacity, coordination in the upper extremitties and cognition in multiple sclerosis patients.FAME - Fampyra outcome measures study: a study of responsiveness of different outcome measures to Fampyra treatment. - FAMEMultiple Sclerosis;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-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sønderjylland Hospital, department of neurologyNot RecruitingFemale: yes
Male: yes
Denmark
712NCT01485003February 7, 201225 February 2019Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative ParticipantsA Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative PatientsRelapsing-Remitting Multiple SclerosisBiological: natalizumabBiogenNot recruiting18 Years65 YearsAll231Phase 2United States
713NCT01433250February 201219 October 2017A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple SclerosisAn Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: AIN457Novartis PharmaceuticalsNot recruiting18 Years55 YearsAll39Phase 2Czech Republic;Russian Federation;Ukraine
714NCT01480076February 201216 December 2017Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple SclerosisAn Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple SclerosisMultiple SclerosisDrug: FampridineBiogenNot recruiting18 Years75 YearsAll901Phase 4Italy;Netherlands;Portugal;United Kingdom;Australia;Belgium;Denmark;France;Germany;United States
715NCT01497262February 201219 October 2017Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisA 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNot recruiting18 Years65 YearsAll162Phase 3Argentina;Brazil;Colombia;Jordan;Malaysia;Mexico;Panama;Peru;Costa Rica
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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sponsor
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agemin
Inclusion_
agemax
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gender
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PhaseCountries
716NCT01516554February 201219 February 2015Oral Testosterone for Fatigue in Male Multiple Sclerosis PatientsA Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis PatientsMultiple Sclerosis;FatigueDrug: Testosterone undecanoate;Drug: placeboHealth Sciences Centre, Winnipeg, ManitobaUniversity of Manitoba;Consortium of Multiple Sclerosis Centers;Manitoba Medical Service FoundationNot recruiting18 Years65 YearsMale3Phase 2Canada
717NCT01569451February 201218 June 2018Comparison of Rituximab Induction Therapy Followed by Glatiramer AcetateA Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Rituximab;Drug: Glatiramer Acetate;Other: PlaceboUniversity of Colorado, DenverRocky Mountain MS Research Group, LLCNot recruiting18 Years55 YearsAll53Phase 2United States
718NCT02305264February 201216 December 2017Imaging of Intracerebral Inflammation in MSImaging of Intracerebral Inflammation in the Progressive Phase of Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary ProgressiveDrug: 18F-DPA-714 and 18F-FDGAssistance Publique - Hôpitaux de ParisRecruiting18 Years65 YearsAll65N/AFrance
719EUCTR2011-002683-24-ES30/01/201226 June 2012A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosisA phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosisRelapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: NU100
Pharmaceutical Form: Solution for injection in pre-filled syringe
Current Sponsor code: NU100
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Betaferon
Product Name: Betaferon
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Nuron Biotech, Inc.AuthorisedFemale: yes
Male: yes
500Phase 3Hungary;Russian Federation;Ukraine;Belarus;Georgia;Bulgaria;Spain;Italy;Croatia;Poland
720EUCTR2011-003775-11-BE12/01/20127 October 2013Fluoxetine therapy for multiple sclerosisFluoxetine therapy for multiple sclerosis - FLUOX-PMSprogressive multiple sclerosis
MedDRA version: 16.0 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 16.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 16.0 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fluoxetine
Product Name: Fluoxetine
Product Code: fluoxetine
Pharmaceutical Form: Capsule
INN or Proposed INN: Fluoxetine
CAS Number: 59333-67-4
Other descriptive name: N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-40
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
AuthorisedFemale: yes
Male: yes
120Belgium
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
721EUCTR2011-003507-38-GB06/01/201228 January 2013Long-Term Prolonged-Release Fampridine Treatment and Quality of LifeAn Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple SclerosisMultiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fampyra
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-
Biogen Idec Research LimitedAuthorisedFemale: yes
Male: yes
800Sweden;United Kingdom;Italy;Germany;Netherlands;Australia;Denmark;Ireland;Belgium;Portugal;France
722NCT01500408January 201219 February 2015Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy VolunteersA Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different ProcessesMultiple SclerosisDrug: Interferon beta-1a (current approved manufacturing process invloving FBS);Drug: Interferon beta-1a (new process, manufactured without FBS)Biogen IdecNot recruiting18 Years45 YearsBoth110Phase 1United States
723NCT01517282January 201219 October 2017Phase Ib Study to Evaluate MOR103 in Multiple SclerosisA Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety and Pharmacokinetics of MOR103, a Human Antibody to GM-CSF, in Patients With Multiple SclerosisMultiple SclerosisBiological: MOR103;Other: PlaceboMorphoSys AGNot recruiting18 Years60 YearsAll32Phase 1/Phase 2Germany;Poland;United Kingdom
724NCT01534182January 201219 October 2017Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Interferon beta - 1a (IFN);Drug: Glatiramer acetate (GA)Novartis PharmaceuticalsNot recruiting18 Years65 YearsAll298Phase 4Russian Federation
725NCT01535664January 201219 October 2017An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MSMultiple SclerosisOther: Withdrawal of dalfampridine-ER 10mgAcorda TherapeuticsPrometrika, LLC;BCS Consulting, Inc.Not recruiting18 Years70 YearsAll20Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
726NCT01601119January 20128 June 2015Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) PatientsThe Impact of Disease Modifying Therapies (DMTs) and Associated Support Services on Patient Reported Experience Measures (PREMs) and Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) PatientsRelapsing Multiple SclerosisDrug: Rebif;Other: Other: Disease modifying therapies (DMT)Merck KGaAMerck Serono Limited, UKNot recruiting18 YearsN/ABoth545N/AUnited Kingdom
727NCT01964547January 201219 October 2017A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis PatientsA Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study of the Effect of Long-term Treatment With Sativex on Cognitive Function and Mood of Patients With Spasticity Due to Multiple SclerosisMultiple Sclerosis;SpasticityDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll121Phase 4Czech Republic
728NCT02280876January 20124 July 2016Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)Randomized, Comparative, Double Blind Controlled Phase II Clinical Trial, to Evaluate the Efficacy of ApE in Patients With Multiple Sclerosis (MS).Multiple Sclerosis, Relapsing-RemittingDrug: 1 - Andrographis paniculata p/st extract;Drug: 2 - ExcipientsUniversidad Austral de ChileComisión Nacional de Investigación Científica y Tecnológica;University of ChileNot recruiting18 Years55 YearsBoth30Phase 1/Phase 2Chile
729NCT01498887December 21, 201116 December 2017Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying TherapyA Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: Fingolimod (FTY720)Novartis PharmaceuticalsNot recruiting18 Years50 YearsAll349Phase 4Australia;Spain
730NCT02967380December 14, 201116 December 2017Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain MetastasesDynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial LesionsAdult Anaplastic (Malignant) Meningioma;Adult Anaplastic Astrocytoma;Adult Anaplastic Ependymoma;Adult Anaplastic Oligodendroglioma;Adult Brain Stem Glioma;Adult Choroid Plexus Neoplasm;Adult Diffuse Astrocytoma;Adult Ependymoblastoma;Adult Ependymoma;Adult Giant Cell Glioblastoma;Adult Glioblastoma;Adult Gliosarcoma;Adult Grade II Meningioma;Adult Medulloblastoma;Adult Mixed Glioma;Adult Oligodendroglioma;Adult Papillary Meningioma;Adult Pineal Gland Astrocytoma;Adult Pineoblastoma;Adult Primary Melanocytic Lesion of Meninges;Adult Supratentorial Primitive Neuroectodermal Tumor;Malignant Adult Intracranial Hemangiopericytoma;Metastatic Malignant Neoplasm in the Brain;Multiple Sclerosis;Recurrent Adult Brain NeoplasmProcedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging;Drug: Gadobenate Dimeglumine;Drug: Gadobutrol;Radiation: Gadopentetate DimeglumineUniversity of Southern CaliforniaNational Cancer Institute (NCI)Not recruiting18 YearsN/AAll14N/AUnited States
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
731EUCTR2011-003570-89-NL02/12/201119 March 2012The effect of interferon beta-1a treatment on adaptability of the brain in patients with MSThe effect of interferon beta-1a treatment on functional adaptation in Multiple Sclerosis (MS) - interferon beta-1a and functional adaptationMultiple sclerosis
MedDRA version: 14.0 Level: PT Classification code 10004504 Term: Beta interferon therapy System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: interferon beta-1a
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 2400000-12000000
VU University Medical CenterAuthorisedFemale: yes
Male: yes
Netherlands
732NCT01377870December 201111 June 2018Evaluation of Autologous Mesenchymal Stem Cell Transplantation (Effects and Side Effects) in Multiple SclerosisEffect and Side Effect of Mesenchymal Stem Cell in Multiple SclerosisMultiple SclerosisBiological: intravenous injection of mesenchymal stem cells;Biological: injection of cell free mediaRoyan InstituteNot recruiting18 Years55 YearsAll22Phase 1/Phase 2Iran, Islamic Republic of
733NCT01440062December 201110 December 2018Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)Phase II Study of Efficacy of Vitamin D Supplementation in Multiple SclerosisMultiple SclerosisDrug: Verum arm receiving Vitamin D oil;Drug: low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second dayCharite University, Berlin, GermanyNeuroCure Clinical Research Center, Charite, BerlinNot recruiting18 Years65 YearsAll55Phase 2Germany
734NCT01470521December 20118 February 2016Worms for Immune Regulation of Multiple SclerosisWorms for Immune Regulation of Multiple Sclerosis (WIRMS)Multiple Sclerosis, Relapsing-RemittingBiological: Hookworm larvae;Biological: PlaceboUniversity of NottinghamNational Multiple Sclerosis SocietyNot recruiting18 Years65 YearsBoth72Phase 2United Kingdom
735NCT02006160December 201113 May 2019Effects of Dalfampridine on Cognition in Multiple SclerosisEffects of Dalfampridine on Cognition in Multiple SclerosisMultiple SclerosisDrug: dalfampridine;Drug: placeboState University of New York at BuffaloNot recruiting18 Years60 YearsAll61Phase 2/Phase 3United 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
736NCT01943526November 30, 201111 June 2018Ireland Natalizumab (TYSABRI) Observational ProgramIreland Natalizumab (TYSABRI®) Observational Program (iTOP)Relapsing-Remitting Multiple SclerosisBiological: natalizumabBiogenNot recruitingN/AN/AAll191Phase 1Ireland
737EUCTR2011-002333-19-DE29/11/201121 September 2015Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMSRelapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 15.0 Level: LLT Classification code 10070716 Term: Multiple sclerosis pseudo relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ofatumumab
Product Code: GSK1841157
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Current Sponsor code: GSK1841157
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
GlaxoSmithKline Research and Development LimitedNot RecruitingFemale: yes
Male: yes
196United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Norway;Germany;Italy
738EUCTR2011-002969-38-DE08/11/201124 July 2012A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phaseA 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase -Fatigue in Patients with relapsing remitting Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
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-
Novartis Pharma GmbHAuthorisedFemale: yes
Male: yes
Germany
739EUCTR2009-015319-41-DE03/11/201117 May 2016Trichuris suis Oozyten (TSO®) in remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS)Trichuris suis Oozyten (TSO®) in remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS) - TRIOMSremittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS) ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]Product Name: TSO
Product Code: TSO
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Trichuris suis ova (eggs), embryonated, viable
Concentration unit: Other
Concentration type: equal
Concentration number: 2500-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Charite Universitätsmedizin BerlinNot RecruitingFemale: yes
Male: yes
Phase 2Germany
740NCT01457924November 1, 201111 June 2018Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Ofatumumab 3mg;Drug: Ofatumumab 30mg;Drug: Ofatumumab 60mg;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years55 YearsAll232Phase 2United States;Bulgaria;Canada;Czechia;Denmark;Germany;Italy;Netherlands;Norway;Russian Federation;Spain;Czech Republic
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
741NCT01451593November 201121 September 2015Neuroprotection With Phenytoin in Optic NeuritisA Phase II Double Blind, Randomized, Placebo Controlled Trial of Neuroprotection With Phenytoin in Acute Optic NeuritisOptic Neuritis;Multiple SclerosisDrug: Phenytoin;Drug: PlaceboUniversity College, LondonNational Multiple Sclerosis Society;Multiple Sclerosis Society of Great Britain and Northern IrelandNot recruiting18 Years60 YearsBoth92Phase 2United Kingdom
742NCT01462318November 201116 December 2017An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple SclerosisA Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: Midazolam;Other: Caffeine;Drug: S-warfarin;Other: Vitamin K;Drug: Omeprazole;Drug: Dextromethorphan;Biological: BIIB019 (Daclizumab)BiogenNot recruiting18 Years65 YearsAll133Phase 3United States;Czech Republic;Hungary;Poland;Russian Federation
743EUCTR2010-020337-99-GB20/10/201122 October 2018A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA IRelapsing Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 8.8-22
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: ocrelizumab 300mg/10ml
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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F.Hoffmann-La RocheAuthorisedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
744EUCTR2010-020315-36-SK18/10/201119 November 2018A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA IIRelapsing Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 8.8-22
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: ocrelizumab 300mg
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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F.Hoffmann-La RocheAuthorisedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
745NCT01285479October 15, 201121 January 2019Pregnancy Registry TrialThe Multi-National Pregnancy Fingolimod Exposure Registry in Multiple Sclerosis (Epidemiological Study Protocol FTY720D2404)Multiple SclerosisDrug: FingolimodNovartis PharmaceuticalsRecruitingN/AN/AFemale500Phase 2United States;Argentina;Australia;Austria;Belgium;Canada;Cyprus;Czechia;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Lebanon;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Spain;Sweden;Switzerland;United Arab Emirates;United Kingdom;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
746NCT01453868October 201119 February 2015The Effects of Aerobics Training on Balance in Patients With Multiple SclerosisThe Effects of Neuromuscular Training on Balance in Patients With Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingOther: Non Impact Aerobics;Other: Passive : lecture seriesNelson Mandela Metropolitan UniversityRecruiting20 Years60 YearsBoth60Phase 0United States
747NCT01464905October 201119 February 2015Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)A Phase 3, Multicenter, Double-blind,Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of NU100 in Patients With Relapsing Forms of Multiple SclerosisRelapsing Remitting Multiple SclerosisBiological: NU100;Biological: Placebo;Biological: rhIFN beta-1bNuron Biotech Inc.Not recruiting18 Years60 YearsBoth500Phase 3Belarus;Bulgaria;Croatia;Georgia;Hungary;Italy;Lebanon;Poland;Russian Federation;Serbia;Spain;Ukraine;India
748NCT01466114October 201111 November 2019Estriol Treatment in Multiple Sclerosis (MS): Effect on CognitionA Double-Blind, Placebo Controlled Trial of Estriol Treatment in Women With Multiple Sclerosis: Effect on Cognition.Relapsing-remitting Multiple Sclerosis;Secondary-progressive Multiple Sclerosis;Primary-progressive Multiple SclerosisDrug: estriol;Other: Placebo;Drug: Norethindrone;Other: Progestin PlaceboUniversity of California, Los AngelesRecruiting18 Years55 YearsFemale64Phase 2United States
749EUCTR2011-000888-27-CZ21/09/201124 August 2015A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATERelapsing remitting multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Current Sponsor code: GTR
Other descriptive name: GTR.ace
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Copaxone
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: Copaxone
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-
Synthon BVNot RecruitingFemale: yes
Male: yes
750Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany
750NCT01412333September 20, 20117 October 2019A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placeboHoffmann-La RocheNot recruiting18 Years55 YearsAll835Phase 3United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Colombia;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;Morocco
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
751EUCTR2011-002785-20-DE19/09/201128 August 2017Efficacy of Vitamin D Supplementation in relapsing-remitting Multiple SclerosisEfficacy of Vitamin D Supplementation in relapsing-remitting Multiple Sclerosis - EVIDIMSMultiple Sclerosis and Clinical isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Vigantol® Öl 20.000 I.E./ml
Product Name: Vigantol® Öl 20.000 I.E./ml
Product Code: Vigantol® Öl 20.000 I.E./ml
Pharmaceutical Form: Oral liquid
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: 25OH-Vitamin D
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 20.000 -
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
Trade Name: Dekristol®-Tablette 1 (400 IE)
Product Name: Dekristol® 400-Tabletten
Product Code: Dekristol® 400-Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Other descriptive name: 25OH-Vitamin D
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 400-
Charité - Universitätsmedizin BerlinNot RecruitingFemale: yes
Male: yes
Phase 2Germany
752EUCTR2010-021219-17-ES12/09/201128 February 2019Evaluación de masitinib en esclerosis múltipleEstudio prospectivo Fase III, multicéntrico, randomizado, doble ciego, de dos grupos paralelos, controlado con placebo y de 96 semanas de duración, para comparar la eficacia y seguridad de masitinib a la dosis de 6 mg/kg/día con placebo en el tratamiento de pacientes con esclerosis múltiple primaria progresiva o esclerosis múltiple secundaria progresiva sin recidivaPacientes con esclerosis múltiple primaria progresiva o secundaria progresiva sin recidiva
MedDRA version: 14.0 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.0 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: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
AB ScienceNot Recruiting Female: yes
Male: yes
450Phase 3France;United States;Czech Republic;Slovakia;Greece;Poland;Spain;Romania;Bulgaria;Germany
753NCT01435993September 8, 201116 December 2017Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple SclerosisA Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis.Multiple Sclerosis, Relapsing-RemittingDrug: GSK1223249;Other: Saline placeboGlaxoSmithKlineNot recruiting18 Years60 YearsAll3Phase 1Germany;Italy;Norway
754NCT01324232September 20119 July 2018Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple SclerosisA Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple SclerosisCentral Neuropathic Pain;Multiple SclerosisDrug: AVP-923;Drug: PlaceboAvanir PharmaceuticalsNot recruiting18 Years85 YearsAll200Phase 2United States;Argentina;Czechia;Poland;Spain;Czech Republic;Germany;United Kingdom
755NCT01360489September 201119 February 2015Arbaclofen Placarbil for the Treatment of Spasticity in Subjects With Multiple Sclerosis (MS)An Open Label, 26-Week Study Assessing Arbaclofen Placarbil Safety and Efficacy in Subjects With Spasticity Associated With Multiple Sclerosis With an Addendum Open-Label, 36-Week Study Assessing Arbaclofen Placarbil Safety in Subjects With Spasticity Associated With Multiple SclerosisMultiple SclerosisDrug: arbaclofen placarbilXenoPort, Inc.Not recruiting18 Years70 YearsBoth218Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
756NCT01444300September 201119 October 2017Dalfampridine for Imbalance in Multiple SclerosisDalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot StudyMultiple Sclerosis;FatigueDrug: Dalfampridine;Drug: PlaceboOregon Health and Science UniversityAcorda TherapeuticsNot recruiting20 Years59 YearsAll24Phase 2United States
757NCT01450124September 201130 March 2015Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA)Safety, Tolerability And Mechanism Of Action Of Boswellic Acids In Multiple Sclerosis and Clinically Isolated Syndrome: A MRI-Controlled, Multicenter, Baseline-To-Treatment, 32-Weeks, Open-Label, Phase IIa TrialRelapsing Remitting Multiple SclerosisDrug: Boswellic acids (BOSWELAN)Universitätsklinikum Hamburg-EppendorfNot recruiting18 Years65 YearsBoth29Phase 2Germany
758EUCTR2011-001442-15-DE26/08/201127 January 2014A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720)relapsing remitting multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Gilenya
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-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
142Greece;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Australia;Denmark;Germany;Norway;Sweden
759NCT01442194August 1, 201126 August 2019Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying TherapiesLong-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying TherapyMultiple SclerosisDrug: other disease-modifying therapy;Drug: FingolimodNovartis PharmaceuticalsRecruitingN/AN/AAll3620N/AUnited States;Argentina;Australia;Canada;Chile;Mexico;Puerto Rico
760NCT01411514August 201128 December 2015Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple SclerosisPhase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino CohortMultiple SclerosisDrug: Prednisone;Drug: PlaceboClaudio GobbiEnte Ospedaliero Cantonale, Ticino, SwitzerlandNot recruiting18 Years80 YearsBoth27Phase 4Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
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Inclusion_
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Target_
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PhaseCountries
761NCT01420055August 201128 November 2016Fingolimod -Response According to Coping - EvaluationA 4-month, Prospective, Open-label, Multi-center Phase IV Study to Assess Response to Fingolimod Initiation According to Coping Profile in Adult Patients With Highly Active Relapsing Remitting Multiple Sclerosis in FranceMultiple Sclerosis, Relapsing-RemittingDrug: fingolimodNovartis PharmaceuticalsNot recruiting18 Years65 YearsBoth189Phase 4France
762NCT01433497August 201113 May 2019Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple SclerosisA 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple SclerosisMultiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Relapse FreeDrug: Masitinib;Drug: PlaceboAB ScienceNot recruiting18 Years75 YearsAll656Phase 3Bulgaria;France;Germany;Greece;Poland;Romania;Spain;United States
763EUCTR2011-001160-21-DE18/07/20114 February 2013Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomideStudy to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVAMultiple sclerosis
MedDRA version: 14.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Trade Name: Mutagrip
Product Name: Mutagrip
Pharmaceutical Form: Injection
sanofi-aventis recherche & developpementNot RecruitingFemale: yes
Male: yes
120Canada;Ukraine;Austria;Russian Federation;Germany
764EUCTR2008-005008-24-GB07/07/201119 March 2012Worms for immune regulation of multiple sclerosis - MS and hookwormWorms for immune regulation of multiple sclerosis - MS and hookwormRelapsing Multiple Sclerosis
MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 13.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Product Name: Necator americanus
Pharmaceutical Form: Spot-on solution
Other descriptive name: Live Necator americanus larvae
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 25 -
Pharmaceutical form of the placebo: Spot-on solution
Route of administration of the placebo: Topical use (Noncurrent)
University of NottinghamAuthorisedFemale: yes
Male: yes
72United Kingdom
765JPRN-UMIN0000058892011/07/012 April 2019The safety and efficacy of tocilizumab in patients with neuromyelitis opticaneuromyelitis opticaTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months.Department of Immunology, National Institute of Neuroscience, NCNPNot Recruiting20years-old65years-oldMale and Female3Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
766NCT01103583July 201119 February 2015Hydroxyurea in Primary Progressive Multiple SclerosisMultiple SclerosisDrug: Hydroxyurea;Other: placeboS. Andrea HospitalNot recruiting18 Years60 YearsBoth33Phase 2/Phase 3Italy
767NCT01417312July 201110 December 2018Metabolic Effects of a Green Tea Extract in Multiple Sclerosis PatientsMultiple Sclerosis, Relapsing-RemittingDietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG);Dietary Supplement: PlaceboCharite University, Berlin, GermanyNot recruiting20 Years60 YearsAll20N/AGermany
768NCT01451723July 201119 October 2017Safety and Neuroprotective Effects of Polyphenon E in MS; Phase IIPhase 2 Randomized Placebo Controlled Trial of Polyphenon E in MSMultiple SclerosisDrug: Polyphenon E;Other: PlaceboLouisiana State University Health Sciences Center in New OrleansNational Center for Complementary and Integrative Health (NCCIH)Not recruiting18 Years60 YearsAll11Phase 2United States
769NCT01699555July 201119 February 2015First-in-Human Study With GNbAC1 in Healthy VolunteersRandomized Placebo-Controlled First-in-Human Study With GNbAC1Multiple SclerosisBiological: GNbAC1;Biological: GNbAC1 placeboGeNeuro Innovation SASNot recruiting18 Years55 YearsMale33Phase 1
770EUCTR2011-000926-31-CZ29/06/201117 June 2013A long term, 50 week, Phase IV multi-centre study to determine if Sativex has an effect on cognition (thinking ability) when prescribed to patients with spasticity due to MSA Multicentre, Double-blind, Randomised Parallel Group, Placebo- controlled Study of the Effect of long-term treatment with Sativex on Cognitive Function and Mood of Patients with Spasticity due to Multiple SclerosisSpasticity in multiple sclerosis (MS).
MedDRA version: 14.1 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: N/A
CAS Number: 1972-08-3
Other descriptive name: delta-9-tetrahydrocannabinol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 27-
INN or Proposed INN: N/A
CAS Number: 13956-29-1
Other descriptive name: cannabidiol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Oromucosal use
GW Pharma Ltd.Not RecruitingFemale: yes
Male: yes
120Phase 4Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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agemin
Inclusion_
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PhaseCountries
771EUCTR2010-024000-10-BE28/06/201117 August 2015A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple SclerosisA Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINERelapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Name: Natalizumab for IV Infusion
Product Code: AN100226; BG00002
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Current Sponsor code: AN100226; BG00002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Natalizumab for Subcutaneous Injection
Product Code: AN100226; BG00002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Current Sponsor code: AN100226; BG00002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Biogen Idec LimitedNot RecruitingFemale: yes
Male: yes
300Phase 2Spain;Belgium;Germany;Italy
772EUCTR2011-001280-49-FR14/06/201119 February 2018« GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude clinique menée dans plusieurs centres français, d'une durée de 4 mois, visant à comparer la réponse à l'initiation du traitement par fingolimod (Gilenya®) selon le profil d'anxiété chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active.« GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude multicentrique de phase IV, prospective, en ouvert, d'une durée de 4 mois, visant à comparer la réponse à l’initiation du fingolimod (Gilenya®) selon le profil de « coping » chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active en France. - GRACESclérose en plaques rémittente-récurrente active
MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
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 -
Novartis Pharma S.A.SNot RecruitingFemale: yes
Male: yes
250Phase 4France
773NCT01395316June 201116 December 2017Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple SclerosisAlemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: AlemtuzumabUniversity of ChicagoGenzyme, a Sanofi CompanyNot recruiting18 Years50 YearsAll8Phase 4
774NCT01428726June 201119 February 2015A Phase IIa Study of NT-KO-003 for Multiple SclerosisA Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of Low Doses of Oral NT-KO-003 for the Treatment of Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: NT-KO-003Neurotec PharmaAdvancell - Advanced In Vitro Cell Technologies, S.A.Not recruiting18 Years55 YearsBoth99Phase 2Germany;Spain
775EUCTR2011-001956-12-CZ25/05/201112 December 2016Biological Efficacy of Interferon ß Therapy in Patients with Multiple SclerosisMonitoring of MxA mRNA Expression as a Marker of Rresponse to Interferon ß Therapy in Patients with Multiple Sclerosis.To correlate bioactivity of IFNß reflected by level of MxA expression and clinical course of MS To measure expression of MxA protein in patients treated with IFNß depending on NAbs status NAbs positive cohorts will be correlated NAbs titer with level of MxA expression, respectively if the MxA decrease is not preceding NAbs positivity. The MxA induction test will be tested.Trade Name: Avonex®
Product Name: Avonex®
Product Code: EU/1/97/033/002
Pharmaceutical Form: Injection
Trade Name: Betaferon®
Product Name: Betaferon®
Product Code: EU/1/95/003/005-010
Pharmaceutical Form: Injection
Trade Name: Rebif 22®
Product Name: Rebif 22®
Product Code: EU/1/98/063/001-003
Pharmaceutical Form: Injection
Trade Name: Rebif 44®
Product Name: Rebif 44®
Product Code: EU/1/98/063/004-006
Pharmaceutical Form: Injection
Trade Name: Extavia®
Product Name: Extavia®
Product Code: EU/1/08/454/001-002, EU/1/08/454/005-007
Pharmaceutical Form: Injection
University Hospital MotolNot RecruitingFemale: yes
Male: yes
Phase 4Czech Republic
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_
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PhaseCountries
776EUCTR2010-024561-43-DK24/05/20115 August 2014Cyclic Oral Methylprednisolone Trial in Multiple SclerosisCyclic Oral Methylprednisolone Trial in Multiple Sclerosisprogressive multiple sclerosis
MedDRA version: 13.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Trade Name: Medrol
Pharmaceutical Form: Tablet
CAS Number: 83-43-2
Other descriptive name: METHYLPREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Scleroseklinikken, RigshospitaletNot RecruitingFemale: yes
Male: yes
30Denmark
777NCT01416363May 20, 201116 December 2017Healthy Volunteer Study Using 3 Different Formulations of FirategrastA Single/Repeat Dose Study With Three Oral Formulations of Firategrast (Immediate Release Tablet, Modified Release Tablet, and Naso-gastric Infusion) in Healthy Male VolunteersMultiple Sclerosis, Relapsing-RemittingDrug: Firategrast immediate release tablet;Drug: Firategrast modified release tablet;Drug: Firategrast gastro-retentive solutionGlaxoSmithKlineNot recruiting18 Years65 YearsMale38Phase 1Australia
778EUCTR2010-024477-39-LV06/05/201116 November 2015A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAINRelapsing Multiple Sclerosis
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]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta 1a
Current Sponsor code: BIIB017
Other descriptive name: PEGylated Intereron Beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 125-
Biogen Idec LimitedNot RecruitingFemale: yes
Male: yes
1600Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
779EUCTR2010-021978-11-SE04/05/20117 December 2015A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Other descriptive name: SUB22282
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Biogen Idec LimitedNot RecruitingFemale: yes
Male: yes
856United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
780NCT01259388May 201111 April 2016A Pilot Study of Lithium in Progressive Multiple SclerosisA Pilot Trial of Lithium in Progressive Multiple SclerosisMultiple SclerosisDrug: Lithium CarbonateVA Office of Research and DevelopmentNot recruiting30 Years65 YearsBoth20Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
781NCT01333358May 201119 February 2015Evaluating Alemtuzumab as a Treatment in Stabilizing Neurocognitive Function In Relapsing Remitting Multiple Sclerosis PatientsPhase III A Prospective, Longitudinal, Rater-blinded Single-arm Study to Evaluate Alemtuzumab as an Effective Treatment in Stabilizing Overall Neurocognitive Function in RRMS Subjects at Specified TimepointsMultiple SclerosisDrug: AlemtuzumabCentral Texas Neurology ConsultantsGenzyme, a Sanofi CompanyNot recruitingN/AN/ABoth30Phase 3
782NCT01337986May 201119 February 2015Ampyra for Optic Neuritis in MSDalfampridine After Optic Neuritis to Improve Visual Function in Multiple SclerosisMultiple Sclerosis;Optic NeuritisDrug: Dalfampridine/Placebo;Drug: Placebo/DalfampridineWashington University School of MedicineAcorda TherapeuticsNot recruiting18 Years55 YearsBoth53Phase 2/Phase 3United States
783NCT01357980May 201126 August 2019Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple SclerosisA Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.Detrusor Muscle HyperactivityBiological: Botulinum toxin type A;Drug: PlaceboIpsenNot recruiting18 Years70 YearsAll47Phase 2Czechia;France;Germany;Italy;Poland;Austria;Czech Republic
784NCT01359566May 201116 December 2017Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple SclerosisA Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple SclerosisMultiple SclerosisDrug: Arbaclofen placarbil 15 mg BID;Drug: Placebo;Drug: Arbaclofen placarbil 30 mg BID;Drug: Arbaclofen placarbil 45 mg BIDIndivior Inc.Not recruiting18 Years70 YearsAll228Phase 3United States
785EUCTR2010-023678-38-IT20/04/201116 February 2015High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - NDHigh-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - NDpatients with multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10028245
Trade Name: MANTADAN*20CPR 100MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Amantadine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: AMPYRA
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Ampyra
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABORNot RecruitingFemale: yes
Male: yes
Italy
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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gender
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size
PhaseCountries
786EUCTR2011-000150-31-IT13/04/201119 March 2012EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY.EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY.Multiple Sclerosis patients
MedDRA version: 14.1 Level: HLGT Classification code 10012303 Term: Demyelinating disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive System Organ Class: 10029205 - Nervous system disorders
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: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: COPAXONE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
Concentration unit: mg milligram(s)
Concentration number: 20-
FONDAZIONE DON CARLO GNOCCHI ONLUSAuthorisedFemale: yes
Male: yes
Italy
787EUCTR2011-000770-60-IT12/04/201117 June 2013“An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND“An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - NDapproximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed.
MedDRA version: 14.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: other nervous system drugs
CAS Number: 162359-56-0
Current Sponsor code: FINGOLIMOD
Concentration unit: mg milligram(s)
Concentration number: .5-
NOVARTIS FARMANot RecruitingFemale: yes
Male: yes
600Italy
788NCT01407211April 201119 February 2015Impact of Vitamin A on Gene Expression, in Multiple Sclerosis PatientThe Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDietary Supplement: vitamin ATehran University of Medical SciencesRecruiting20 Years45 YearsBoth30Phase 4Iran, Islamic Republic of
789EUCTR2010-023560-40-SE23/03/201121 October 2013Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MISTRelapsing-remitting multiple sclerosis
MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Trade Name: Tysabri
Pharmaceutical Form:
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: Sendoxan
Pharmaceutical Form: Powder for solution for injection
CAS Number: 6055192
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Pharmaceutical Form: Powder for infusion*
CAS Number: 0
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Pharmaceutical Form: Solution for injection
Trade Name: Solu-Medrol
Pharmaceutical Form: Powder and solvent for dispersion for injection
Uppsala l?ns landstingAuthorisedFemale: yes
Male: yes
120United States;Canada;Brazil;Sweden
790EUCTR2010-023677-19-IT23/03/20113 April 2012Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010PATIENT WITH RRMS AND SPMS
MedDRA version: 13.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive System Organ Class: 10029205 - Nervous system disorders
Trade Name: BETAFERON*15CONFEZ 0,25MG/ML+
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1b
Concentration unit: µmole/ml micromole(s)/millilitre
Concentration type: equal
Concentration number: 250-
Trade Name: EXTAVIA*SC 15FL 250MCG/ML+15SI
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1b
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: equal
Concentration number: 250-
Trade Name: DIBASE
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Colecalciferol
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 2000-
AZIENDA OSPEDALIERA S. LUIGI GONZAGAAuthorisedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
791EUCTR2010-024017-31-IT15/03/201128 August 2014A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDENA 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDENRelapsing Remitting Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399
Product Name: FINGOLIMOD
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Trade Name: EXTAVIA
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1b
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Trade Name: AVONEX
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Trade Name: COPAXONE
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Glatiramer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
NOVARTIS FARMANot RecruitingFemale: yes
Male: yes
Italy
792NCT01194570March 2, 20119 September 2019A Study of Ocrelizumab in Participants With Primary Progressive Multiple SclerosisA Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Other: PlaceboHoffmann-La RocheNot recruiting18 Years55 YearsAll732Phase 3United States;Uruguay;Czech Republic;Germany;Greece;Hungary;Israel;France;Finland;Denmark;Czechia;Canada;Bulgaria;Brazil;Belgium;United Kingdom;Ukraine;Turkey;Switzerland;Spain;Russian Federation;Romania;Portugal;Poland;Peru;Norway;New Zealand;Netherlands;Mexico;Lithuania;Italy;Australia;Austria
793NCT00813969March 201111 April 2016Autologous Mesenchymal Stem Cell (MSC) Transplantation in MSA Phase I Study to Assess the Feasibility, Safety, and Tolerability of Autologous Mesenchymal Stem Cell Transplantation in Patients With Relapsing Forms of Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Progressive Relapsing Multiple SclerosisBiological: Autologous mesenchymal stem cell transplantationThe Cleveland ClinicUniversity Hospital Case Medical CenterNot recruiting18 Years55 YearsBoth24Phase 1United States
794NCT01328379March 201119 October 2017Study of Fampridine-ER Tablets in Patients With Multiple SclerosisDouble-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Doses of Oral Dalfampridine Extended Release Tablets (5 mg and 10 mg Twice Daily) in Patients With Multiple SclerosisMultiple SclerosisDrug: Dalfampridine-ER 5mg;Drug: Dalfampridine-ER 10mg;Other: PlaceboAcorda TherapeuticsNot recruiting18 Years70 YearsAll430Phase 3United States
795EUCTR2010-023021-38-SE23/02/201123 November 2015Switch To RItuXimab in MS A phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSSwitch To RItuXimab in MS A phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSRelapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate
MedDRA version: 12.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Västerbottens läns landstingNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
796EUCTR2010-023172-12-NL15/02/201114 January 2013Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLESMultiple 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: 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: 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-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
sanofi-aventis recherche et developmentNot RecruitingFemale: yes
Male: yes
1455United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden
797NCT01281657February 201119 February 2015Long Term Study of Fingolimod in MS Patients From the FTY Clinical ProgramA Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development ProgramMultiple SclerosisDrug: fingolimodNovartisNot recruiting18 YearsN/ABoth64N/AUnited States;Canada
798NCT01310166February 201128 November 2016Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple SclerosisA 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNot recruiting18 Years65 YearsBoth447Phase 4Germany
799NCT02073474February 201116 December 2017An Observational Post-Marketing Safety Registry of Sativex®An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex®Multiple Sclerosis;Diabetes;Cancer;Neuropathic PainDrug: Sativex®GW Pharmaceuticals Ltd.Not recruitingN/AN/AAll978N/A
800EUCTR2010-022066-28-DE18/01/201130 April 2018A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosisA 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosisrelapsing remitting Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Gilenya
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Other descriptive name: Fingolimod
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Novartis Pharma GmbHNot RecruitingFemale: yes
Male: yes
445Phase 3Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
801EUCTR2010-020338-25-PT12/01/201128 February 2019A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - OratorioPrimary 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]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: OCREVUS
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/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/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F.Hoffmann-La RocheAuthorised Female: yes
Male: yes
630Phase 3United States;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand
802EUCTR2010-022033-28-NL10/01/20116 May 2013A study investigating safety, tolerability and efficacy of ECP002A (?9-THC) in Multiple Sclerosis patients suffering from spasticity and pain.A two-phased, randomized, double blind, placebo-controlled study of ECP002A (?9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain. - ECP002A (?9-THC) in MS patientsMultiple 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: Namisol
Product Code: ECP002A
Pharmaceutical Form: Tablet
INN or Proposed INN: dronabinol
CAS Number: 1972-08-03
Current Sponsor code: ECP002A
Other descriptive name: Namisol
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1.5-5.0
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Echo Pharmaceuticals B.V.Not RecruitingFemale: yes
Male: yes
Netherlands
803NCT01071694January 201119 February 2015QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in KoreaQOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in KoreaMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/ABoth0N/AKorea, Republic of
804NCT01454791January 201119 October 2017Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer AcetateDiclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover TrialMultiple SclerosisDrug: diclofenac sodium topical gel;Other: PlaceboBrown, Theodore R., M.D., MPHTeva Neuroscience, Inc.Not recruiting18 YearsN/AAll40Phase 4United States
805NCT01455220January 201116 December 2017The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple SclerosisThe Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple SclerosisMultiple SclerosisDrug: Tysabri ® (Natalizumab)University of South FloridaNot recruiting18 Years60 YearsAll45N/AUnited States
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_
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Target_
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PhaseCountries
806EUCTR2011-001692-39-DE9 December 2013A study to evaluate the safety and tolerability of the combination of an antidepressive therapy with oral fingolimod in the treatment of relapsing remitting multiple sclerosis patients with mild to moderate depressionA 21-week, multicenter, open label study to evaluate the safety and tolerability profile of the combination of a SSRI or SNRI antidepressive therapy with oral fingolimod in the treatment of RRMS patients with mild to moderate depressionMultiple Sclerosis Depression
MedDRA version: 14.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Gilenya
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Trade Name: Venlafaxin Hexal
Product Name: Venlafaxin Hexal
Pharmaceutical Form: Capsule, hard
CAS Number: 99300-78-4
Other descriptive name: VENLAFAXINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: Fluoxetin Hexal
Product Name: Fluoxetin Hexal
Pharmaceutical Form: Tablet
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
CAS Number: 59333-67-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Venlafaxin Hexal
Product Name: Venlafaxin Hexal
Pharmaceutical Form: Capsule, hard
CAS Number: 99300-78-4
Other descriptive name: VENLAFAXINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Fluoxetin Hexal
Product Name: Fluoxetin Hexal
Pharmaceutical Form: Tablet
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
CAS Number: 59333-67-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: Gilenya
Product Name: Gilenya
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Novartis Pharma GmbHNot RecruitingFemale: yes
Male: yes
Germany
807EUCTR2010-020337-99-LV29/12/201010 September 2018A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA IRelapsing Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 8.8-22
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: ocrelizumab 300mg/10ml
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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use
F.Hoffmann-La RocheAuthorisedFemale: yes
Male: yes
800Phase 3Hungary;Mexico;Argentina;Czech Republic;United Kingdom;Austria;Lithuania;Finland;Latvia;Tunisia;Netherlands;South Africa;Peru;Australia;Switzerland;Italy;Russian Federation;Chile;Israel;Ukraine;Spain;Slovakia;Morocco;Estonia;Serbia;United States;Portugal;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
808EUCTR2010-023023-19-IT28/12/201011 April 2016A 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - NDA 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - NDrelapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399
Product Name: FINGOLIMOD
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Trade Name: EXTAVIA
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1b
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
NOVARTIS FARMANot RecruitingFemale: yes
Male: yes
Germany;Italy
809NCT01466322December 22, 201016 December 2017A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers.An Open-label, Randomised, Crossover Study to Assess the Relative Bioavailability of Different 2mg Formulations of GSK2018682(S1P1 Agonist) in Healthy VolunteersMultiple Sclerosis, Relapsing-RemittingDrug: GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed stateGlaxoSmithKlineNot recruiting18 Years55 YearsAll16Phase 1Australia
810EUCTR2010-023996-25-BE21/12/201019 August 2013The effect of fluoxetine and 5-HT4 serotonin receptor agonists on cerebral axonal energy metabolism and glutamate levels in multiple sclerosis.The effect of fluoxetine and 5-HT4 serotonin receptor agonists on cerebral axonal energy metabolism and glutamate levels in multiple sclerosis.Multiple sclerosis (both relapsing remitting and progressive forms)Product Name: fluoxetine
Pharmaceutical Form: Coated tablet
CAS Number: 54910-89-3
Other descriptive name: FLUOXETINE
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 20-40
Product Name: Cisapride
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CISAPRIDE
CAS Number: 81098604
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 10-20
Product Name: Prucalopride
Pharmaceutical Form: Coated tablet
INN or Proposed INN: PRUCALOPRIDE
CAS Number: 179474818
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 1-2
AuthorisedFemale: yes
Male: yes
32Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
811EUCTR2009-017978-21-DE20/12/201028 February 2019Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE RegistryMultiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Cladribine
CAS Number: 4291-63-8
Current Sponsor code: EMD280922
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Merck Serono S.A. - GenevaNot RecruitingFemale: yes
Male: yes
2175Phase 3Serbia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Korea, Republic of;Tunisia;Latvia;Netherlands;Denmark;Australia;Macedonia, the former Yugoslav Republic of;France;India;Switzerland;Italy;Russian Federation;Lebanon;Ukraine;Spain;Thailand;Greece;Morocco;Estonia;Taiwan;Saudi Arabia;United Arab Emirates;United States;Portugal;Georgia;Bulgaria;Norway;Germany;Sweden
812EUCTR2009-017939-18-GB15/12/201019 March 2012A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with Multiple Sclerosis. - Recurrent urine infection in MSA Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with Multiple Sclerosis. - Recurrent urine infection in MSChronic urinary tract infection.
MedDRA version: 14.0 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 10038359 - Renal and urinary disorders
Trade Name: Nitrofurantoin
Product Name: Nitrofurantoin
Product Code: PL 12762/0049
Pharmaceutical Form: Capsule
INN or Proposed INN: Nitrofurantoin
CAS Number: 67-20-9
Other descriptive name: Nitrofurantoin
Concentration unit: Bq/mg becquerel(s)/milligram
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
UCLH/UCL Biomedical Research UnitAuthorisedFemale: yes
Male: yes
Phase 4United Kingdom
813EUCTR2010-020338-25-FI15/12/201028 February 2019A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - OratorioPrimary 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]
Product Name: ocrelizumab 300 mg
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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Ocrevus
Product Name: ocrelizumab 300 mg
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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
F.Hoffmann-La RocheAuthorised Female: yes
Male: yes
630Phase 3Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Germany;Norway
814NCT01228266December 201019 February 2015Mesenchymal Stem Cell Transplantation in MSAutologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II StudyMultiple SclerosisBiological: autologous mesenchymal stem cellsAlbert SaizInstituto de Salud Carlos IIINot recruiting18 Years50 YearsBoth9Phase 2Spain
815NCT01235221December 201019 February 2015Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension TrialsMultiple SclerosisDrug: BIIB041 (Fampridine-SR)Biogen IdecAcorda TherapeuticsNot recruiting18 Years70 YearsBoth38Phase 3Canada
No.TrialIDDate_
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816NCT01318421December 201021 December 2015A Study of ELND002 in Patients With Relapsing Forms of Multiple SclerosisAn Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: ELND002Elan PharmaceuticalsNot recruiting18 Years65 YearsBoth12Phase 1
817NCT01712373December 201019 February 2015Ginseng in Treatment of Fatigue in Multiple SclerosisStudy of Ginseng in Treatment of Fatigue in Multiple SclerosisFatigueDrug: Ginseng;Drug: PlaceboIsfahan University of Medical SciencesNot recruiting18 Years50 YearsBoth60Phase 2Iran, Islamic Republic of
818NCT00939549November 20101 October 2018High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisPhase II Study of High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Cyclophosphamide/Glatiramer acetateJohns Hopkins UniversityNot recruiting18 Years70 YearsAll0Phase 2United States
819NCT01236534November 201019 October 2017Lubiprostone in Patients With Multiple Sclerosis Associated ConstipationSingle-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated ConstipationMultiple Sclerosis;ConstipationDrug: Lubiprostone;Drug: PlaceboUniversity of RochesterTakedaNot recruiting18 YearsN/AAll21Phase 4United States
820NCT01356940November 201019 October 2017A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple SclerosisA Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple SclerosisMultiple SclerosisDrug: dalfampridine ER;Drug: placeboBrown, Theodore R., M.D., MPHAcorda TherapeuticsNot recruiting18 Years75 YearsAll43Phase 4United States
No.TrialIDDate_
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821NCT01440101November 201019 October 2017Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B)Multiple SclerosisDrug: Placebo;Drug: Natalizumab (BG00002)BiogenNot recruiting18 Years65 YearsAll106Phase 2/Phase 3Japan;China
822NCT01667796November 201018 March 2019Pharmacokinetics of Vitamin D in Multiple Sclerosis and in HealthPharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy ControlsMultiple Sclerosis, Relapsing-remittingDietary Supplement: Vitamin D3Johns Hopkins UniversityUniversity of California, San Francisco;National Multiple Sclerosis SocietyNot recruiting18 Years60 YearsFemale57N/AUnited States
823EUCTR2010-020328-23-FI21/10/20104 August 2015Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment.A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif® SOLAR Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLARRelapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: 200109, EMD 28162, 300910
Other descriptive name: Cholecalciferol, Vitamin D3
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Merck SeronoNot RecruitingFemale: yes
Male: yes
230Phase 2Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
824NCT01431937October 10, 201016 December 2017Assessment of Repeat Ascending Doses of GSK2018682 in Healthy VolunteersA Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Ascending Doses of GSK2018682 (S1P1 Agonist) in Healthy VolunteersMultiple Sclerosis, Relapsing-RemittingDrug: GSK2018682;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years55 YearsAll40Phase 1Australia
825NCT01005095October 201019 February 2015The Effects of Interferon Beta Combined With Vitamin D on Relapsing Remitting Multiple Sclerosis PatientsA One Year Prospective, Randomized, Double Blind Interventional Study to Assess Tolerability, Quality of Life and Immunomodulation With Interferon Beta Combined With Vitamin D in Patients With Relapsing Remitting Multiple SclerosisMULTIPLE SCLEROSISDietary Supplement: Vitamin D3Carmel Medical CenterNot recruiting18 Years65 YearsBoth45Phase 4Israel
No.TrialIDDate_
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826NCT01188811October 201019 October 2017Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)Lipoic Acid for Neuroprotection in Secondary Progressive MSMultiple Sclerosis, Chronic ProgressiveDrug: lipoic acid;Drug: PlaceboVA Office of Research and DevelopmentOregon Health and Science UniversityNot recruiting40 Years70 YearsAll54Phase 2/Phase 3United States
827NCT01244139October 201016 December 2017Safety Study of BIIB033 in Subjects With Multiple SclerosisA Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: BIIB033;Drug: PlaceboBiogenNot recruiting18 Years60 YearsAll47Phase 1United States
828NCT01279876October 201024 August 2015Melatonin in Relapsing-Remitting Multiple Sclerosis PatientsEffects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis PatientsMultiple Sclerosis, Relapsing-RemittingDrug: MelatoninTehran University of Medical SciencesNot recruiting20 Years45 YearsBoth25Phase 2Iran, Islamic Republic of
829NCT01381354October 20102 July 2018Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)Multiple SclerosisOther: Progressive exercise;Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV;Other: Modified paleolithic diet;Dietary Supplement: Omega 3 fatty acids;Dietary Supplement: Full Spectrum vitamin;Dietary Supplement: Essential - hydroxytyrosol;Dietary Supplement: Maltodextrin fiber supplement;Dietary Supplement: Mineral boost (magnesium);Dietary Supplement: Niacinamide;Dietary Supplement: Methyl B12;Dietary Supplement: Taurine;Dietary Supplement: creatine;Dietary Supplement: thiamine;Dietary Supplement: riboflavin;Dietary Supplement: N acetylcysteine;Dietary Supplement: alpha lipoic acid;Dietary Supplement: L acetyl carnitine;Dietary Supplement: methyl folate;Dietary Supplement: coenzyme Q;Behavioral: meditation;Behavioral: self massage;Behavioral: learning;Dietary Supplement: Coconut oilUniversity of IowaDirect MS Canada;DJO Incorporated;Pinnaclife Inc.;TZ Press, LLCNot recruiting18 Years65 YearsAll38Phase 1United States
830NCT01416155October 201019 October 2017Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple SclerosisA Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: natalizumabBiogenNot recruiting18 Years65 YearsAll97Phase 2Japan;China
No.TrialIDDate_
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831EUCTR2010-018705-11-BE13/09/201017 August 2015A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSISA SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSISRelapsing-remitting Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ONO-4641/MSC2430913A
Product Code: ONO-4641/MSC2430913A
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ONO-4641/MSC2430913A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.05-
Product Name: ONO-4641/MSC2430913A
Product Code: ONO-4641/MSC2430913A
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ONO-4641/MSC2430913A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-
Product Name: ONO-4641/MSC2430913A
Product Code: ONO-4641/MSC2430913A
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ONO-4641/MSC2430913A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.15-
Merck Serono S.A. - GenevaNot RecruitingFemale: yes
Male: yes
376United States;Czech Republic;Greece;Canada;Spain;Belgium;Ukraine;Russian Federation;Germany;Japan
832JPRN-JapicCTI-10133501/9/20102 April 2019An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic PainAn Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, PainIntervention name : pregabalin
INN of the intervention : pregabalin
Dosage And administration of the intervention : pregabalin capsules 150mg/day, 300mg/day, 450mg/day or 600mg/day BID
Control intervention name : null
Pfizer Japan Inc.18BOTH100Phase 3
833NCT01116427September 201019 October 2017A Cooperative Clinical Study of Abatacept in Multiple SclerosisA Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: abatacept;Drug: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Not recruiting18 Years65 YearsAll65Phase 2United States;Canada
834NCT01181089September 201019 February 2015Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF) and Safety in Subjects With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisBiological: Placebo;Biological: BaminerceptBiogen IdecNot recruiting18 Years57 YearsBoth0Phase 1/Phase 2Canada;United Kingdom
835NCT01202227September 201019 October 2017An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic PainAn Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)Spinal Cord Diseases;Spinal Cord Injuries;Neuralgia;PainDrug: pregabalinPfizerNot recruiting18 YearsN/AAll104Phase 3Japan
No.TrialIDDate_
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836NCT01212094September 201019 October 2017Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)Multiple SclerosisDrug: Rituximab;Other: normal salineNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years65 YearsAll44Phase 1/Phase 2United States
837EUCTR2010-020515-37-FI06/08/201019 November 2018Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosisA single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.multiple sclerosis
MedDRA version: 19.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden
838NCT00997438August 201019 October 2017Defining the Anti-inflammatory Role of Lipoic Acid in Multiple SclerosisDefining the Anti-inflammatory Role of Lipoic Acid in Multiple SclerosisMultiple SclerosisDietary Supplement: Lipoic AcidPortland VA Medical CenterOregon Health and Science UniversityNot recruiting18 YearsN/AAll69Phase 1United States
839NCT01191996August 201019 February 2015Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple SclerosisA Phase 2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered MIS416 in Patients With Chronic Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisBiological: MIS416Innate ImmunotherapeuticsPrimorus Clinical Trials;National Multiple Sclerosis SocietyNot recruiting18 YearsN/ABoth34Phase 1/Phase 2New Zealand
840NCT01216072August 201019 October 2017A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple SclerosisA 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)Relapsing Forms of Multiple SclerosisDrug: Fingolimod;Drug: Standard MS DMTsNovartis PharmaceuticalsNot recruiting18 Years65 YearsAll1053Phase 4United States;Canada;Puerto Rico
No.TrialIDDate_
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841NCT01337427August 201019 February 2015Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple SclerosisOptical Coherence Tomography (OCT) in a Multicenter, Randomized,Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BIIB017Johns Hopkins UniversityBiogen IdecNot recruiting18 Years55 YearsBoth0Phase 3United States
842EUCTR2009-011888-37-DE23/07/201010 December 2012A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALTA 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALTosteoporosis in patients with multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10049088 Term: Osteopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Aclasta 5 mg Infusionslösung
Product Name: Aclasta
Product Code: ZOL446H
Pharmaceutical Form: Solution for infusion
CAS Number: 165800-06-6
Other descriptive name: ZOLEDRONIC ACID MONOHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma GmbHNot RecruitingFemale: yes
Male: yes
Germany
843EUCTR2009-009503-19-BE20/07/201021 August 2017A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMERA prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMERMultiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Natalizumab
Current Sponsor code: BG00002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Biogen Idec International GmbHNot RecruitingFemale: yes
Male: yes
200Phase 4Belgium
844EUCTR2010-019028-30-FI07/07/201023 May 2012A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis.A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis.Relapsing forms of multiple sclerosis.
MedDRA version: 12.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
120Finland;United Kingdom;France;Spain
845NCT01167426July 201019 October 2017Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) PatientsAn Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method.Multiple SclerosisDrug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mLTeva Neuroscience, Inc.Not recruiting18 YearsN/AAll148Phase 3United States
No.TrialIDDate_
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846NCT01207648July 201019 October 2017Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)Retrospective Cohort Study of Rebif® Use in Pediatric MS PatientsMultiple SclerosisDrug: Rebif®EMD SeronoNot recruitingN/A18 YearsAll307N/AUnited States;Argentina;Canada;France;Italy;Russian Federation;Tunisia;Venezuela
847NCT01085318June 201019 October 2017Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot TrialA Twenty-four Week, Two Arm, Pilot Trial to Evaluate Remyelination/ Demyelination, Gray Matter Volume and Iron Deposition in the Central Nervous System (CNS) and Immune Status of Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) Treated With Rebif® 44 Mcg Subcutaneously (sc) Three Times a Week (Tiw) Compared to a Healthy Control GroupMultiple SclerosisDrug: RebifEMD SeronoNot recruiting18 Years65 YearsAll38Phase 4United States
848NCT01144052June 201019 October 2017Natalizumab De-escalation With Interferon Beta-1bDe-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: interferon beta-1b;Drug: NatalizumabClaudio GobbiOspedale Civico, LuganoNot recruiting18 Years60 YearsAll19Phase 4Switzerland
849NCT01149525June 201016 December 2017Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple SclerosisA Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple SclerosisMultiple SclerosisDrug: L-Carnitine;Drug: PlaceboUniversity Hospital, BordeauxNot recruiting18 YearsN/AAll59Phase 3France
850NCT01156311June 201016 December 2017BG00012 Phase 2 Combination Study in Participants With Multiple SclerosisAn Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNß) or Glatiramer Acetate (GA)Relapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: dimethyl fumarateBiogenNot recruiting18 Years55 YearsAll108Phase 2United States
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851NCT01067521May 31, 201016 December 2017A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to PlaceboA Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind DesignRelapsing Remitting Multiple SclerosisDrug: Glatiramer acetate (GA);Other: PlaceboTeva Pharmaceutical Industries, Ltd.Not recruiting18 Years55 YearsAll1404Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Poland;Romania;Russian Federation;South Africa;Ukraine;United Kingdom;Czech Republic;Turkey
852NCT01047319May 27, 201021 January 2019A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple SclerosisA Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: LaquinimodTeva Pharmaceutical Industries, Ltd.Not recruitingN/AN/AAll1047Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;Macedonia, The Former Yugoslav Republic of;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Puerto Rico
853NCT01387217May 21, 201016 December 2017GSK2018682 FTIH in Healthy VolunteersA Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy VolunteersMultiple SclerosisDrug: GSK2018682;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years55 YearsAll27Phase 1Australia
854NCT01143441May 13, 201011 November 2019Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis (MS)Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis (MS)Multiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingBiological: DAC-HYPNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years60 YearsAll48Phase 1United States
855NCT01093326May 12, 201016 September 2019Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple SclerosisMulticenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mgActelionNot recruiting18 Years55 YearsAll353Phase 2United States;Austria;Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Czech Republic
No.TrialIDDate_
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856EUCTR2010-019029-32-DE06/05/201022 October 2012A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.Relapsing multiple sclerosis.
MedDRA version: 12.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse
Product Name: FTY720
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod hydrochloride
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
2400Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden
857EUCTR2009-017490-38-DE03/05/201024 April 2012Randomized Treatment Interruption of Natalizumab - RESTORERandomized Treatment Interruption of Natalizumab - RESTORENatalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS). This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months.
MedDRA version: 12.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Other descriptive name: TYSABRI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: Copaxone
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GLATIRAMER ACETATE
CAS Number: 147245-92-9
Other descriptive name: COPAXONE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: AVONEX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Other descriptive name: AVONEX
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Trade Name: Urbason Forte
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 83-43-2
Other descriptive name: URBASON FORTE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Biogen IdecNot RecruitingFemale: yes
Male: yes
200Germany;Spain
858NCT01006941May 201019 February 2015Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety StudyTrichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety StudyRelapsing Multiple SclerosisBiological: Trichuris suis ovaRigshospitalet, DenmarkUniversity of Copenhagen;Statens Serum Institut;Copenhagen University Hospital, Hvidovre;OvaMed GmbHNot recruiting19 Years55 YearsBoth10Phase 2Denmark
859NCT01076595May 20103 August 2015Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years PeriodProspective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus ProgramMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/ABoth73N/AFrance
860NCT01354665May 201019 February 2015Depression and Fatigue in MS Patients Treated With Betaferon.The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis.Multiple SclerosisBiological: Interferon beta-1b (Betaferon, BAY86-5046)BayerNot recruiting18 YearsN/ABoth567N/APoland
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
861NCT01842191May 201019 February 2015Efficacy of Fish Oil in Multiple SclerosisEfficacy of Fish Oil on Serum TNFa, IL-1ß, IL-6, Oxidative Stress Markers in Multiple Sclerosis Treated With Interferon Beta 1-bRelapsing- Remitting Multiple SclerosisDietary Supplement: Fish Oil;Dietary Supplement: PlaceboCoordinación de Investigación en Salud, MexicoNot recruiting18 Years55 YearsBoth50Phase 4Mexico
862EUCTR2009-012500-11-IE12/04/201023 February 2015Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDERelapsing-remitting Multiple Sclerosis
MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab
Current Sponsor code: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: AVONEX
Pharmaceutical Form: Solution for injection
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
1800Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden
863EUCTR2009-017003-28-IT12/04/201023 December 2013Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like SymdromeRelationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdromemultiple sclerosis
MedDRA version: 9.1 Level: SOC Classification code 10029205
MedDRA version: 9.1 Level: HLGT Classification code 10012303
MedDRA version: 9.1 Level: HLT Classification code 10052785
MedDRA version: 9.1 Level: LLT Classification code 10063399
Trade Name: AVONEX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
BIOGEN-DOMPE` SRLNot RecruitingFemale: yes
Male: yes
Italy
864EUCTR2009-016824-29-DK06/04/201019 March 2012REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIRREsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIRMultiple Sclerosis
MedDRA version: 12.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: Multiferon
Pharmaceutical Form: Solution for injection
INN or Proposed INN: HUMAN LEUCOCYTE INTERFERON-ALPHA
CAS Number: 0
Current Sponsor code: SWEDISH ORPHAN INTERNATIONAL
Other descriptive name: HUMAN LEUCOCYTE INTERFERON-ALPHA
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 6000000-
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 220581-49-7
Current Sponsor code: Merck Serono
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 22-44
Trade Name: Betaferon
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: INTERFERON BETA-1B
CAS Number: 145155-23-3
Current Sponsor code: Bayer
Other descriptive name: INTERFERON BETA-1B
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 8000000-
Dansk Multipel Sclerose CenterNot RecruitingFemale: yes
Male: yes
10Denmark
865NCT01071512April 201016 December 2017Tysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisTysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisMultiple SclerosisDrug: TysabriUniversity of ChicagoBiogenNot recruiting18 Years60 YearsAll20N/AUnited States
No.TrialIDDate_
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866NCT01181115April 201019 February 2015Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: AvonexBiogen IdecNot recruiting18 Years55 YearsBoth60Phase 3China
867EUCTR2009-011470-15-FI30/03/201026 November 2018An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosisrelapsing-remitting multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
ACTELION Pharmaceuticals LtdAuthorisedFemale: yes
Male: yes
353Phase 2Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
868EUCTR2008-005167-33-DE29/03/201013 June 2016Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAXEffect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAXPatients with cerebellar ataxia with coordination deficits in walking, upper and lower limb movements and oculomtoor coordination deficits are included in the trial. The cause of their atayia is either a degenerative CNS disease (36 patients) such as autosomal dominant Spinocerebellar Ataxia or sporadic ataxia with late onset or inflammatory CNS disease (Multiple Sclerosis; 36 patients).Trade Name: Neurontin 300 mg hard capsule
Product Name: gabapentine 300mg
Product Code: GBP
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Gabapentin
CAS Number: 60142-96-3
Current Sponsor code: 1210
Other descriptive name: GABAPENTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Charité University Medicine BerlinNot RecruitingFemale: yes
Male: yes
Phase 4Germany
869EUCTR2009-014339-19-CZ26/03/201019 March 2012A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSISA DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSISRelapsing-remitting Multiple Sclerosis
MedDRA version: 12.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Code: ONO-4641
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: 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
Product Code: ONO-4641
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: 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
Product Code: ONO-4641
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ONO-4641
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.15-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
ONO Pharmaceutical Co., Ltd.Not RecruitingFemale: yes
Male: yes
376Germany;Czech Republic;Spain;Greece
870EUCTR2009-011088-35-DE24/03/201019 March 2012Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUSPituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUSPatients with Multiple Sclerosis (MS) or Clinically isolated syndrome suggestive for MS (CIS) are investigated. The main objective is to conserve data about changes in the VIP/PACAP (vasoactive intestinal polypaptide/pituitary adenylate cyclase activating polypeptide) system in stresses patients who start a immunomodulatory treatment with glatiramer acetate (Copaxone).Trade Name: Copaxone
Product Name: copaxone
Product Code: 52069.00.01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Philipps-Universität MarburgAuthorisedFemale: yes
Male: yes
Germany
No.TrialIDDate_
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871NCT01024777March 201019 February 2015Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple SclerosisA Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple SclerosisMultiple Sclerosis;Vitamin D DeficiencyDrug: CholecalciferolJohns Hopkins UniversityNot recruiting18 Years55 YearsBoth40Phase 1United States
872NCT01058005March 201019 October 2017Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BG00002 (natalizumab);Drug: interferon beta-1a;Drug: glatiramer acetateBiogenElan PharmaceuticalsNot recruiting18 Years60 YearsAll84Phase 3United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden
873NCT01070823March 201017 October 2016JC-Virus (JCV) Antibody ProgramJCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1Multiple SclerosisDrug: Tysabri® (natalizumab)BiogenUnited BioSource Corporation;Elan Pharmaceuticals;United BioSource Corporation;Elan PharmaceuticalsNot recruitingN/AN/ABoth1096N/AUnited States
874NCT01070836March 201010 October 2016JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With NatalizumabJCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2Relapsing Multiple SclerosisDrug: natalizumabBiogenNot recruitingN/AN/ABoth35895N/AUnited States;Puerto Rico
875NCT01071083March 201019 October 2017Treatment Interruption of NatalizumabRandomized Treatment Interruption of NatalizumabRelapsing Remitting Multiple SclerosisDrug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetateBiogenElan PharmaceuticalsNot recruiting18 Years60 YearsAll175Phase 2United States;Germany;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
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876NCT01077466March 201019 February 2015Natalizumab Treatment of Progressive Multiple SclerosisNatalizumab Treatment of Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: NatalizumabRigshospitalet, DenmarkCopenhagen University Hospital, Hvidovre;Biogen Idec;University of Copenhagen;Signifikans ApSNot recruiting19 Years55 YearsBoth24Phase 2Denmark
877NCT01097668March 201019 October 2017ATX-MS-1467 in Patients With Relapsing Forms of Multiple SclerosisSAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).Relapsing Remitting Multiple SclerosisBiological: ATX-MS-1467Apitope Technology (Bristol) Ltd.Aptiv Solutions;ClinStar, LLCNot recruiting18 Years55 YearsAll43Phase 1Russian Federation;United Kingdom
878NCT01144351March 201021 December 2015A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple SclerosisA Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: ELND002;Drug: PlaceboElan PharmaceuticalsNot recruiting18 Years65 YearsBoth32Phase 1United States;Canada
879NCT01424423February 11, 201016 December 2017NOGO-A in Multiple Sclerosis FTIHA Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying TherapyMultiple SclerosisDrug: Placebo;Drug: GSK1223249GlaxoSmithKlineNot recruiting18 Years55 YearsAll3Phase 1Australia
880EUCTR2009-015934-30-FR02/02/20103 April 2017étude randomisée en double insu et crossover comparant l’efficacité de la L-carnitine à un placebo dans le traitement de la fatigue dans la sclérose en plaques - FACTSEPétude randomisée en double insu et crossover comparant l’efficacité de la L-carnitine à un placebo dans le traitement de la fatigue dans la sclérose en plaques - FACTSEPsclérose en plaque fatigue
MedDRA version: 12.0 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: levocarnil
Product Name: Levocarnil
Product Code: na
Pharmaceutical Form: Oral solution
INN or Proposed INN: L-carnitine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
CHU de BordeauxNot RecruitingFemale: yes
Male: yes
Phase 3France
No.TrialIDDate_
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881EUCTR2009-014857-34-DE01/02/201020 May 2013Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MSIntra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MSPatients with clinically definite MS or a clinically isolated episode of CNS involvement and disease dissemination in space, according to the McDonald’s criteria
MedDRA version: 12.0 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Gadovist 1.0 mmol/ml Injektionslösung
Product Code: V08CA09
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOBUTROL
CAS Number: 138071-82-6
Other descriptive name: GADOBUTROL
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number: 1.0-
Trade Name: Dotarem 0,5mmol/ml,
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gadoteric acid
CAS Number: 92923-44-9
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration number: 0,5-
Universitätsklinikum ErlangenAuthorisedFemale: yes
Male: yes
50Germany
882NCT00988988February 201019 February 2015The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate InjectionsThe Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer AcetateMultiple SclerosisDrug: AGEE cream;Drug: 1% Steroid Cream;Drug: topical placebo cream with no active ingredientsUniversity of NebraskaTeva Pharmaceutical IndustriesNot recruiting19 Years65 YearsBoth0Phase 4United States
883NCT01065727February 201019 February 2015Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple SclerosisStudy Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple SclerosisMultiple SclerosisOther: mitoxantrone - immunomodulator;Other: natalizumabRennes University HospitalRecruiting18 YearsN/ABoth250N/AFrance
884NCT01073813February 201019 February 2015Neuroprotection and Repair in Optic NeuritisDeveloping Neuroprotection and Repair Strategies in MS: Phase IIa Randomized, Controlled Trial of Minocycline in Acute Optic Neuritis (ON)Multiple Sclerosis;Optic NeuritisDrug: MinocyclineUniversity of CalgaryNeuroscience CanadaNot recruiting18 Years60 YearsBoth6Phase 2Canada
885NCT01414634February 201019 October 2017Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear CellsEstablish Tolerance in Multiple Sclerosis With Peptide-coupled, Peripheral Blood Mononuclear Cells - A MRI-controlled, Single Center, Phase I Trial in Relapsing-remitting MS PatientsMultiple Sclerosis, Relapsing-RemittingBiological: ETIMSUniversitätsklinikum Hamburg-EppendorfNot recruiting18 Years55 YearsAll9Phase 1/Phase 2
No.TrialIDDate_
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886NCT01417273February 201019 February 2015Impact of Vitamin A on Multiple Sclerosis (MS)Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) PatientsRelapsing Remitting Multiple SclerosisDietary Supplement: vitamin A;Drug: Drug: placeboTehran University of Medical SciencesRecruiting20 Years45 YearsBoth100Phase 4Iran, Islamic Republic of
887NCT01705457February 201019 February 2015Impact of Vitamin A on RAR Gene Expression in Multiple SclerosisImpact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic PatientsRelapsing Remitting Multiple SclerosisDrug: Dietary Supplement: vitamin A;Drug: placeboTehran University of Medical SciencesRecruiting20 Years45 YearsBoth20Phase 4Iran, Islamic Republic of
888EUCTR2009-012431-15-CZ21/01/201019 March 2012Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání. Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®.Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání. Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®.Studie se zabývá lécbou hyperaktivního neurogeního detruzoru u pacientu, kterí trpí príznaky hyperaktivního mocového mechýre jako dusledek spinálního poranení nebo roztroušené sklerózy. K lécbe se pužívá botulinumotoxin. Ve studii se porovnávaní dve ruzné formy aplikace studjiního léku.Trade Name: Botox
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 8000049323
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Krajská nemocnice Liberec, a.s.AuthorisedFemale: yes
Male: yes
40Czech Republic
889EUCTR2009-015318-23-CZ21/01/201019 September 2016A study designed to determine safety and efficacy of Daclizumab High Yield Process (DAC HYP) in patients with Multiple Sclerosis Who Have Completed Treatment in a previous study, 205MS202 (SELECTION)A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)Relapsing-remitting Multiple Sclerosis
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Daclizumab High Yield Process
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab
Current Sponsor code: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Biogen Idec Ltd.Not RecruitingFemale: yes
Male: yes
450Phase 2Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India
890EUCTR2009-016140-39-ES19/01/201019 March 2012MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple.MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple.Realce de contraste en resonancia magnética en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple con resonancia magnética anormal anterior después de la administración de dosis única y acumulada de GADOVIST® High field strength MRI in patients with clinically isolated syndromes or relapsing MS with abnormal previous MRI after single and double dose of Gadovist®Trade Name: GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOBUTROL
Other descriptive name: GADOBUTROL
Concentration unit: mmol/kg millimole(s)/kilogram
Concentration type: equal
Concentration number: 0.2-
Institut Diagnostic per la ImatgeAuthorisedFemale: yes
Male: yes
Spain
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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891EUCTR2007-001496-11-GB15/01/201028 February 2019The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis - Multiple Sclerosis Tetanus Vaccine for Reduction of Inflammation-1The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis - Multiple Sclerosis Tetanus Vaccine for Reduction of Inflammation-1Multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple Sclerosis
Trade Name: Revaxis
Product Name: Revaxis
Pharmaceutical Form: Injection*
University of NottinghamNot Recruiting Female: yes
Male: yes
46Phase 2United Kingdom
892EUCTR2009-016703-35-DK08/01/20102 September 2013Natalizumabbehandling af progressiv multipel sklerose - NAPMSNatalizumabbehandling af progressiv multipel sklerose - NAPMSSecondary progressive multiple sclerosis and primary progressive multiple sclerosis
MedDRA version: 12.0 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
MedDRA version: 12.0 Level: LLT Classification code 10063401 Term: Primary progressive multiple sclerosis
Trade Name: Tysabri
Product Name: Natalizumab
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Current Sponsor code: Natalizumab
Other descriptive name: Tysabri
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Dansk Multipel Sclerose CenterNot RecruitingFemale: yes
Male: yes
24Denmark
893NCT01031459January 201019 February 2015Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Betaseron (Interferon beta-1b, BAY86-5046)BayerNot recruiting18 YearsN/ABoth176N/AUnited States;Canada
894NCT01101776January 201019 February 2015Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical SettingMultiple SclerosisDrug: Interferon beta-1a (Rebif)Merck KGaAMerck Serono Australia Pty LtdNot recruiting18 YearsN/ABoth49N/AAustralia
895NCT01364246January 201019 February 2015Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis OpticaPhase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis OpticaProgressive Multiple Sclerosis;Neuromyelitis Optica.Biological: human umbilical cord mesenchymal stem cellsShenzhen Beike Bio-Technology Co., Ltd.The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School;The Affiliated Nanjing Brain Hospital of Nanjing University Medical School;Nanjing University Medical College Affiliated Wuxi Second Hospital;Xuzhou Medical College;The Second Hospital of Nanjing Medical UniversityRecruiting18 Years60 YearsBoth20Phase 1/Phase 2China
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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896EUCTR2009-012716-40-EE31/12/200919 March 2012The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis: A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialThe Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis: A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialRelapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: PI-2301
Product Code: PI-2301
Pharmaceutical Form: Solution for injection
CAS Number: 1026791-66-1
Current Sponsor code: PI-2301 acetate salt
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: PI-2301
Product Code: PI-2301
Pharmaceutical Form: Solution for injection
CAS Number: 1026791-66-1
Current Sponsor code: PI-2301 acetate salt
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Copaxone
Product Name: Copaxone
Pharmaceutical Form: Solution for injection
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Peptimmune Inc.Not RecruitingFemale: yes
Male: yes
350Phase 2Germany;Czech Republic;Bulgaria;France;Estonia;Poland
897EUCTR2008-008554-23-SE29/12/200919 March 2012Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNFNeutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNFIFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation).
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Rebif
Product Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 145258-61-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-44
The Multiple Sclerosis Research Group, Department of Clinical NeuroscienceNot RecruitingFemale: yes
Male: yes
100Sweden
898EUCTR2009-016087-37-ES18/12/200924 April 2012Estudio farmacogenético exploratorio, multinacional, multicéntrico y con una sola toma de muestras de sangre del ensayo REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease). A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGxEstudio farmacogenético exploratorio, multinacional, multicéntrico y con una sola toma de muestras de sangre del ensayo REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease). A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGxEsclerosis Múltiple
MedDRA version: 12.0 Level: PT Classification code 10028245 Term: Multiple sclerosis
Product Name: Rebif
Pharmaceutical Form: Solution for injection
Product Name: Copaxone
Pharmaceutical Form: Solution for injection
Merck Serono S.A. - GenevaNot RecruitingFemale: yes
Male: yes
325United Kingdom;France;Ireland;Spain;Italy
899NCT00963833December 17, 200916 December 2017Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple SclerosisStudy Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting12 Years16 YearsAll68N/AAustria;Belgium;Finland;Germany;Israel;United Kingdom;Italy;Portugal
900EUCTR2009-013284-19-AT10/12/200910 July 2015Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABSImmune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABSmultiple sclerosis patients with neutralizing antibodies against interferon-betaTrade Name: Betaferon
Pharmaceutical Form: Intravenous infusion
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 48-
Medical University InnsbruckNot RecruitingFemale: yes
Male: yes
Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
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901NCT00913510December 200919 October 2017Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder DysfunctionEfficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple SclerosisBladder Dysfunction;Multiple SclerosisDevice: CIC using LoFric Primo;Drug: Anticholinergic medicationWellspect HealthCareNot recruiting18 YearsN/AAll24N/ABelgium;Germany;Netherlands;United Kingdom;France
902NCT00986960December 200915 July 2019Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up StudyMultiple SclerosisDrug: repository corticotropin injection;Drug: SalineUniversity at BuffaloNot recruiting18 Years65 YearsAll3Phase 2United States
903NCT01037088December 200919 October 2017Effects of Vaporized Marijuana on Neuropathic PainCCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic PainNeuropathic Pain;Reflex Sympathetic Dystrophy;Peripheral Neuropathy;Post-herpetic Neuralgia;Spinal Cord Injury;Multiple SclerosisDrug: CannabisUniversity of California, DavisCenter for Medicinal Cannabis Research;VA Northern California Health Care SystemNot recruiting18 Years70 YearsAll44Phase 1/Phase 2United States
904NCT02442557December 200925 May 2015Safety and Dose-finding Study of DC-TAB in Healthy SubjectsA Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and T-cell Tolerizing Effect of DC-TAB in Healthy VolunteersMultiple SclerosisBiological: recombinant human alpha B-crystallin;Other: placebo comparatorDelta Crystallon BVNot recruiting18 Years55 YearsBoth76Phase 1Netherlands
905NCT01013350November 30, 200926 August 2019Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical TrialsProspective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical TrialsMultiple SclerosisDrug: CladribineEMD SeronoNot recruitingN/AN/AAll1191Phase 1/Phase 2United States
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
906EUCTR2008-004408-29-DE27/11/200919 March 2012ESTABLISH TOLERANCE IN MS WITH PEPTIDE-PULSED, PERIPHERAL BLOOD MONONUCLEAR CELLS - A MRI-CONTROLLED, SINGLE CENTER, BASELINE-TO-TREATMENT CROSS-OVER, PHASE I/IIA TRIAL IN RELAPSING-REMITTING MS PATIENTS - ETIMS - - ETIMSESTABLISH TOLERANCE IN MS WITH PEPTIDE-PULSED, PERIPHERAL BLOOD MONONUCLEAR CELLS - A MRI-CONTROLLED, SINGLE CENTER, BASELINE-TO-TREATMENT CROSS-OVER, PHASE I/IIA TRIAL IN RELAPSING-REMITTING MS PATIENTS - ETIMS - - ETIMSrelapsing-remitting Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: ETIMS (EDC-fixed autologous PBMCs coupled with 7 immunodominant myelin peptides in MS patients)
Product Code: ETIMS
Pharmaceutical Form: Intravenous infusion
University Medical Center Hamburg-EppendorfAuthorisedFemale: yes
Male: yes
Phase 1/2AGermany
907EUCTR2009-013884-21-DE18/11/200924 November 2014A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Prednisolone Sodium Phosphate
CAS Number: 125-02-0
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 1.0-3.2
Trade Name: Solu-Medrol
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
CAS Number: 03/03/2375
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Enceladus Pharmaceuticals BVNot RecruitingFemale: yes
Male: yes
90Poland;Belgium;Germany
908EUCTR2009-012989-30-GB17/11/200917 October 2016A clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - -Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: ABR-215062 sodium salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
Teva Pharmaceutical Industries LtdAuthorisedFemale: yes
Male: yes
542Phase 3Serbia;United States;Estonia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Georgia;Netherlands;Germany;Sweden
909NCT00988052November 10, 200921 January 2019A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease CourseA Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MSRelapsing Multiple SclerosisDrug: LaquinimodTeva Pharmaceutical Industries, Ltd.Not recruiting18 Years55 YearsAll839Phase 3United States;Austria;Bulgaria;Canada;Czechia;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;Latvia
910NCT01028209November 200915 April 2019Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F] PBR06Institute for Neurodegenerative DisordersNot recruiting18 YearsN/AAll12Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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911NCT01037907November 200919 February 2015A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMSRelapsing Remitting Multiple SclerosisDrug: Pleneva TM BGC20-0134;Drug: PlaceboBTG International Inc.Not recruiting18 Years65 YearsBoth173Phase 2Belgium;France;Germany;Poland;Russian Federation;Spain;Italy
912NCT01049451November 200916 December 2017Pulse ACTH vs. MP for MSComparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif)Multiple SclerosisDrug: ACTH;Drug: MethylprednisoloneUniversity of Southern CaliforniaNot recruiting18 Years65 YearsAll23Phase 1United States
913NCT01615887November 200919 February 2015Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple SclerosisEffects of Lisdexamfetamine on Bradyphrenia in Multiple SclerosisMultiple SclerosisDrug: lisdexamfetamine sulfate;Drug: placeboState University of New York at BuffaloNot recruiting18 Years55 YearsBoth63Phase 2United States
914NCT01719159November 200928 November 2016Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple SclerosisIntrathecal Therapy With Monoclonal Antibodies in Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: RituximabAnders SvenningssonVästerbotten County Council, SwedenNot recruiting18 Years65 YearsBoth23Phase 2Sweden
915EUCTR2009-011626-34-SE28/10/200915 May 2012A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: AIN457
Product Code: AIN457
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: not available
CAS Number: not availabl
Current Sponsor code: AIN457
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
88Czech Republic;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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916EUCTR2009-013695-46-FR22/10/200914 March 2016ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - cholineETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - cholineSclérose en plaques récurrente (SEP-R)
MedDRA version: 12.0 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: UVEDOSE 100 000 UI, solution buvable en ampoule
Product Name: UVEDOSE 100 000 UI
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 50000-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
MERCK SERONO s.a.sNot RecruitingFemale: yes
Male: yes
France
917EUCTR2008-005021-11-BE14/10/200912 June 2012An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension studyAn open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension studyRelapsing multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: atacicept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Product Name: atacicept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Product Name: atacicept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Merck Serono SA - Geneva, An affiliate of Merck KGaA, Darmstadt, GermanyNot RecruitingFemale: yes
Male: yes
68Phase 2Czech Republic;Belgium;France;Sweden
918NCT00787722October 10, 200915 April 2019Hematopoietic Stem Cell Transplant in Devic's DiseaseTrial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's DiseaseDevic's DiseaseProcedure: Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Drug: G-CSF;Drug: rATG;Drug: Mesna;Drug: Rituximab;Drug: MethylprednisoloneNorthwestern UniversityNot recruiting16 Years65 YearsAll13Phase 1/Phase 2United States
919EUCTR2008-007459-28-DE08/10/200919 November 2012Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: LY2127399
Product Code: LY2127399
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: N/a
CAS Number: N/a
Current Sponsor code: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-120
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes
245France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany
920EUCTR2009-011585-28-DE08/10/20094 March 2013Early phase clinical trial to evaluate the effectiveness and safety of a new orally administered drug in patients with relapsing-remitting multiple sclerosisA randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)relapsing-remitting multiple sclerosis
MedDRA version: 14.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BCG20-0134
Product Code: BCG20-0134
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BGC20-0134
Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
BTG International LtdNot RecruitingFemale: yes
Male: yes
184Phase 2aFrance;European Union;Spain;Belgium;Russian Federation;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
921NCT01006265October 1, 200916 December 2017Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple SclerosisMulticenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: ACT-128800 Dose 1;Drug: Placebo;Drug: ACT-128800 Dose 2;Drug: ACT-128800 Dose 3ActelionNot recruiting18 Years55 YearsAll464Phase 2United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom
922NCT00947895October 200911 April 2016Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) MethylprednisoloneRelative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot StudyMultiple SclerosisDrug: Methylprednisolone;Drug: ACTH;Other: IV placebo;Other: IM placeboNeurologique Foundation, Inc.MallinckrodtNot recruiting18 YearsN/ABoth30Phase 2/Phase 3United States
923NCT01225289October 200919 October 2017Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis PatientsThe Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple SclerosisRelapsing Remitting Multiple SclerosisDietary Supplement: Vitamin A;Drug: PlaceboTehran University of Medical SciencesNot recruiting20 Years45 YearsAll36Phase 4Iran, Islamic Republic of
924NCT02275741October 200910 December 2018Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple SclerosisStudy to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal)Dr. med. Micha LoebermannNot recruiting18 Years70 YearsAll226Phase 2Germany
925EUCTR2006-001152-12-DE14/09/200911 April 2016An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period.An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period.Multiple Sclerosis
MedDRA version: 16.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
sanofi-aventis recherche & développementNot RecruitingFemale: yes
Male: yes
780France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;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
926NCT00910598September 200919 February 2015Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)A Multicenter Longitudinal Cross-sectional Pilot Study, to Compare RNFL Thickness Measured by OCT After Treatment With Glatiramer or After no Treatment in Patients With CIS With or Without Optic Neuritis or With Early RRMSMultiple SclerosisDrug: glatiramer acetateAmphia HospitalSanofi;TEVA PharmachemieRecruiting18 Years55 YearsBoth60Phase 4Netherlands
927NCT00981084September 200919 October 2017Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover StudyMultiple SclerosisDrug: armodafinilUniversity of Missouri, Kansas CityUniversity of KansasNot recruiting18 Years60 YearsAll33Phase 2/Phase 3United States
928EUCTR2009-013333-24-IT03/08/200919 March 2012Multicenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE) - BRIDGEMulticenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE) - BRIDGERELAPSING MULTIPLE SCLEROSIS
MedDRA version: 12.0 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: REBIF
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
MERCK SERONO SPANot RecruitingFemale: yes
Male: yes
Phase 4Italy
929NCT00871780August 200916 December 2017A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) PatientsA Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER StudyRelapsing Remitting Multiple Sclerosis (RRMS)Drug: BG00002 (natalizumab)BiogenElan PharmaceuticalsNot recruiting18 Years60 YearsAll224Phase 4Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela
930NCT00930553August 200916 December 2017An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabAn Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of AlemtuzumabMultiple Sclerosis, Relapsing-RemittingBiological: alemtuzumabGenzyme, a Sanofi CompanyBayerNot recruitingN/AN/AAll1314Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
931NCT00940719August 200919 February 2015Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot StudyMultiple SclerosisDietary Supplement: vitamin D3Maastricht University Medical CenterOrbis Medical CentreNot recruiting18 YearsN/ABoth15N/ANetherlands
932NCT00970333August 200919 February 2015Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological ConditionsEvaluation of [18F] FEPPA and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F]-FEPPAInstitute for Neurodegenerative DisordersNot recruiting18 YearsN/ABoth3Phase 1United States
933EUCTR2009-010661-23-IT30/07/200919 March 2012MITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDYMITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDYsubjects affected by secondary-progressive Multiple Sclerosis
MedDRA version: 9.1 Level: SOC Classification code 10029205
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Mitoxantrone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Glatiramer acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLINot RecruitingFemale: yes
Male: yes
Italy
934NCT00950248July 22, 200920 August 2018Double Blind Placebo-Controlled Phase I/II Clinical Trial of Idebenone in Patients With Primary Progressive Multiple Sclerosis (IPPoMS)Double Blind Placebo-Controlled Phase I/II Clinical Trial of Idebenone in Patients With Primary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisDrug: IdebenoneNational Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 Years65 YearsAll85Phase 1/Phase 2United States
935EUCTR2009-013129-41-NL20/07/200919 March 2012A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCTA multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCTclinical isolated syndrome
MedDRA version: 9.1 Level: LLT Classification code 10028248 Term: Multiple sclerosis-like syndrome
Trade Name: Copaxone
Product Name: Copaxone
Pharmaceutical Form: Solution for injection
CAS Number: 147245929
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Amphia ZiekenhuisAuthorisedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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Inclusion_
agemax
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PhaseCountries
936EUCTR2008-002626-11-SE02/07/200924 July 2017Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosisIntrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSITSevere progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Trade Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: RITUXIMAB
Dept of NeurologyNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
937NCT00947752July 200916 December 2017Safety of New Formulation of Glatiramer AcetateAn Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous InjectionRelapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Experimental Glatiramer AcetateTeva Pharmaceutical IndustriesNot recruiting18 YearsN/AAll147Phase 3United States
938NCT00965497July 200919 October 2017Escitalopram (Lexapro) for Depression MS or ALSAn Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple SclerosisMajor Depression;Multiple Sclerosis;Amyotrophic Lateral SclerosisDrug: escitalopramUniversity of South CarolinaNot recruiting18 Years70 YearsAll13Phase 3United States
939EUCTR2009-011234-99-DE23/06/20093 February 2014A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administered daily in subjects with relapsing remitting multiple sclerosis (RRMS)A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administered daily in subjects with relapsing remitting multiple sclerosis (RRMS) - MS-LAQ-101Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis (RRMS). This study is planned to assess the tolerability and safety of escalating doses of oral laquinimod administered daily in subjects with RRMS.
MedDRA version: 15.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: ABR-215062 sodium salt
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 Capsules 0.3 mg
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: ABR-215062 sodium salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Teva Pharmaceutical Industries LtdNot RecruitingFemale: yes
Male: yes
160Phase 1Germany
940EUCTR2009-011523-31-GB23/06/200919 March 2012A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VACA study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VACThe vaccinations are being used to investigate immunological memory following treatment of multiple sclerosis with the lympho-depleting humanised monoclonal antibody alemtuzumab.
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10046859 Term: Vaccination
Trade Name: Menitorix
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Pneumovax II
Pharmaceutical Form: Solution for injection
Trade Name: REVAXIS
Pharmaceutical Form: Suspension for injection
R & D, Cambridge University HospitalsNot RecruitingFemale: yes
Male: yes
60United Kingdom
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
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Target_
size
PhaseCountries
941EUCTR2008-006333-27-LV19/06/200927 January 2014A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCEA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCERelapsing Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Pharmaceutical Form: Solution for injection
Current Sponsor code: BIIB017
Other descriptive name: PEGylated Interferon Beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 63-125
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Biogen Idec LTDNot RecruitingFemale: yes
Male: yes
1260Czech Republic;Estonia;Greece;Spain;Belgium;Bulgaria;Netherlands;Germany;Latvia;United Kingdom
942EUCTR2008-006786-92-CZ18/06/200919 March 2012Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisrelapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: ACT-128800
Product Code: ACT-128800
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: ACT-128800
Product Code: ACT-128800
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ACT-128800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Actelion Pharmaceuticals LtdAuthorisedFemale: yes
Male: yes
460Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden
943EUCTR2008-007549-29-DK09/06/200919 March 2012Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS ATrichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS ARelapsing Multipel Sclerosis
MedDRA version: 12.0 Level: LLT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 12.0 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 12.0 Level: LLT Classification code 10053395 Term: Progressive multiple sclerosis
Product Name: Trichuris suis Ova
Product Code: TSO
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Trichuris suis eggs
Current Sponsor code: Trichuris suis eggs
Other descriptive name: Trichuris suis eggs
Concentration unit: thousand organisms/ml thousand organisms/millilitre
Concentration type: range
Concentration number: 0,15-0,183
Danish Multiple Sclerosis Research CenterNot RecruitingFemale: yes
Male: yes
10Denmark
944NCT00917839June 200919 February 2015The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple SclerosisRandomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.Relapsing-Remitting Multiple SclerosisDrug: lamotrigineCantonal Hospital of St. GallenRecruiting18 Years50 YearsBoth88Phase 2Switzerland
945NCT00942214June 200919 February 2015Biomarkers and Response to Natalizumab for Multiple Sclerosis TreatmentBiomarkers Associated With Response to Natalizumab in Multiple Sclerosis Patients. A Prospective Multicentric Open Label Phase IV StudyMultiple SclerosisDrug: NatalizumabUniversity Hospital, ToulouseNot recruiting18 Years55 YearsBoth300Phase 4France
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
946EUCTR2009-011516-37-DK29/05/20098 August 2016Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMSDouble blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMSMultiple Sclerosis, with primary and secondary progressive courses.
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: NeoRecormon
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Solu-Medrol
CAS Number: 2375033
Current Sponsor code: Pfizer
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous drip use (Noncurrent)
Danish Multiple Sclerosis Research CentreNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
947NCT00799890May 200910 December 2018Sunphenon in Progressive Forms of Multiple SclerosisMonocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple SclerosisMultiple SclerosisDrug: Sunphenon EGCG;Drug: PlaceboFriedemann PaulTAIYO EUROPENot recruiting18 Years65 YearsAll60Phase 2/Phase 3Germany
948NCT00854750May 200919 February 2015Modeling and Treating the Pathophysiology of Demyelination in Multiple SclerosisModeling and Treating the Pathophysiology of Demyelination in Multiple SclerosisMultiple SclerosisDrug: ACTHARElliot FrohmanQuestcor Pharmaceuticals, Inc.Not recruiting18 Years65 YearsBoth1Phase 4United States
949NCT00902135May 20093 August 2015Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)Relapsing-Remitting Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/ABoth702N/AGermany
950NCT01075880May 200919 February 2015Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With RebifMultiple Sclerosis, Relapsing-RemittingDrug: Rebif (Interferon beta-1a)Merck KGaAMerck spol.s.r.o., Czech RepublicNot recruiting18 Years65 YearsBoth300N/ACzech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
951EUCTR2008-007447-14-IT03/04/20097 January 2013GH-IGF-I status and Multiple Sclerosis: clinical implications (a prevalence study).GH-IGF-I status and Multiple Sclerosis: clinical implications (a prevalence study).patients with Multiple Sclerosis
MedDRA version: 14.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Somatorelin
Concentration unit: µg microgram(s)
Concentration number: 50-
UNIVERSITA' DEGLI STUDI DI NAPOLI FEDERICO IIAuthorisedFemale: yes
Male: yes
Italy
952NCT00764413April 200919 February 2015Chronotherapy in Acute Multiple Sclerosis (MS) AttackTreatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?Multiple SclerosisDrug: methylprednisolone;Drug: Sodium chloridSykehuset Innlandet HFNot recruiting18 YearsN/ABoth57N/ANorway
953NCT00881205April 200919 October 2017Rivastigmine in Multiple Sclerosis Patients With Cognitive ImpairmentA 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment PhaseMultiple Sclerosis;Cognitive ImpairmentDrug: Rivastigmine transdermal patch;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 Years65 YearsAll86Phase 4Germany
954NCT00882999April 200926 November 2018A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNot recruiting18 Years64 YearsAll245Phase 2United States;Bulgaria;Czechia;France;Germany;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;Belgium;Canada;Czech Republic;Denmark;Finland;Switzerland
955NCT00904826April 200919 October 2017An Open Label Study of the Effects of Eculizumab in Neuromyelitis OpticaAn Open Label Study of the Effects of Eculizumab in Neuromyelitis OpticaNeuromyelitis Optica;Devic's DiseaseDrug: EculizumabMayo ClinicAlexion PharmaceuticalsNot recruiting18 YearsN/AAll14Phase 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
956NCT00914290April 200916 December 2017A Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisA Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisSpasticity;Multiple SclerosisDrug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IRIMPAX Laboratories, Inc.Not recruiting18 YearsN/AAll23Phase 2United States
957EUCTR2008-006226-34-ES25/03/200910 July 2015Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante ------------------------------------------------------------ A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENEREEstudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante ------------------------------------------------------------ A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENEREEsclerosis Múltiple ------------------------ Multiple sclerosisProduct Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Trade Name: REBIF 44 microgramos solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
sanofi-aventis recherche et developmentNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy
958EUCTR2007-004452-36-GB24/03/200925 September 2012A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator -Multiple sclerosis
MedDRA version: 15.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Teriflunomide
Product Code: HMR 1726D
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sanofi-aventis recherche & développementAuthorisedFemale: yes
Male: yes
1110Germany;France;Austria;Australia;Sweden;Czech Republic;Tunisia;Canada;Belarus;Belgium;Greece;United States;Philippines;Poland;Turkey;Netherlands;Chile;United Kingdom;Slovakia;Ukraine;Mexico;Estonia;China;Romania;Spain;Thailand
959NCT00884481March 23, 200919 November 2018Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMSA Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 MonthsRelapsing-Remitting Multiple Sclerosis;FatigueOther: NatalizumabBiogenNot recruiting18 Years65 YearsAll195Phase 2Austria;Denmark;Norway;Sweden;United States
960EUCTR2008-008065-35-SE13/03/200924 July 2012A multi-centre and prospective trial to evaluate the effects on mul-tiple sclerosis related fatigue during treatment with Tysabri® in patients with relapsing remitting multiple sclerosis over the course of 12 months - TYNERGYMutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10016256 Term: Fatigue
Trade Name: Tysabri
Pharmaceutical Form: Intravenous infusion
BiogenIdec A/SNot RecruitingFemale: yes
Male: yes
200Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
961EUCTR2008-004174-40-FR06/03/200919 March 2012Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEPImagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEPGroupe I: volontaires sains Groupe II: patients avec une sclérose en plaques d'évolution rémittente .
MedDRA version: 8.1 Level: PT Classification code 10012300 Term: Demyelinating disease (excl multiple sclerosis)
Product Name: 11C-PIB
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 11C-PIB
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 740-
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)AuthorisedFemale: yes
Male: yes
France
962NCT00818038March 200919 February 2015A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder FunctionPhase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder FunctionRelapsing-Remitting Multiple SclerosisDrug: BG0002 (natalizumab)Biogen IdecNot recruiting18 Years85 YearsBoth30N/AUnited States
963NCT00853762March 200916 December 2017Atacicept in Multiple Sclerosis Extension Study, Phase IIAn Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)Relapsing Multiple SclerosisDrug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mgEMD SeronoMerck KGaANot recruiting18 Years60 YearsAll74Phase 2United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
964NCT00879658March 200912 March 2018Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple SclerosisA Phase II, Double-blind, Randomized, Multi-center, Adaptive Dose-ranging, Placebo-controlled, Parallel-group Study Evaluating Safety, Tolerability and Efficacy on MRI Lesion Parameters and Determining the Dose Response Curve of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis.Relapsing-remitting Multiple SclerosisDrug: BAF312;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 Years55 YearsAll296Phase 2United States;Canada;Finland;Germany;Hungary;Italy;Norway;Poland;Russian Federation;Spain;Switzerland;Turkey
965NCT02021825March 200919 February 2015Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum DisordersEfficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum DisordersNeuromyelitis Optica;Neuromyelitis Optica Spectrum DisordersDrug: MitoxantroneXuanwu Hospital, BeijingRecruiting18 Years55 YearsBoth50Phase 4China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
966NCT00837785February 28, 200926 February 2018A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MSA 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BG00012BiogenNot recruiting18 Years55 YearsAll48Phase 1Germany;United Kingdom
967EUCTR2008-000256-26-GB16/02/200930 June 2014An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1aAn exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1aMultiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Mitoxantrone
Product Name: Mitoxantrone
Product Code: PL 04515/0127
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Rebif®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Mitoxantrone
CAS Number: 70476-82-3
Concentration unit: 1X 100 milligrams/millilitre
Concentration type: up to
Queen Mary, University of LondonNot RecruitingFemale: yes
Male: yes
15Phase 2aUnited Kingdom
968EUCTR2008-005304-93-GB13/02/200919 March 2012A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosisA Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosisBone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease.
MedDRA version: 9.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse
MedDRA version: 9.1 Level: LLT Classification code 10065687 Term: Bone loss
Trade Name: Aclasta 5mg solution for infusion
Product Name: Aclasta
Product Code: ZOL446H
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
North Bristol TrustNot RecruitingFemale: yes
Male: yes
United Kingdom
969EUCTR2008-005906-38-FR09/02/200919 March 2012Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaquesDétermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaquessclérose en plaques
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Tysabri
Product Name: Tysabri
Pharmaceutical Form: Solution for injection
CHU de ToulouseAuthorisedFemale: yes
Male: yes
300France
970EUCTR2007-002627-32-CZ04/02/20096 January 2015efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosisA double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis.Primary progressive multiple sclerosis.
MedDRA version: 17.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359- 56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
970Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;South Africa;Netherlands;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
971NCT03408093February 3, 20092 July 2018Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1bCross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1bMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 Years100 YearsAll120Phase 1/Phase 2
972NCT00836719February 200919 October 2017Safety of Polyphenon E in Multiple Sclerosis Pilot StudySafety and Neuroprotective Effects of Polyphenon E in Multiple SclerosisMultiple SclerosisDrug: Polyphenon ELouisiana State University Health Sciences Center in New OrleansNational Center for Complementary and Integrative Health (NCCIH)Not recruiting18 Years65 YearsAll10Phase 1United States
973EUCTR2008-001999-67-ES30/01/200926 June 2012Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple ___________________________________________________________________ A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple SclerosisEstudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple ___________________________________________________________________ A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple SclerosisEsclerosis Múltiple ______________ Multiple Sclerosis
MedDRA version: 11.0 Level: LLT Classification code 10028245 Term:
Product Name: Nerispirdine hydrochloride
Product Code: HP184
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Nerispirdine hydrochloride
CAS Number: 119229-64-0
Current Sponsor code: HP184
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
sanofi-aventis Recherche & DéveloppementAuthorisedFemale: yes
Male: yes
368Finland;Germany;France;Spain
974EUCTR2008-005559-46-CZ23/01/200926 August 2013An Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis who have completed Treatment in the study 205MS201 (SELECT)A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) - SELECTIONRelapsing-remitting Multiple Sclerosis
MedDRA version: 14.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab with Greek suufix
Current Sponsor code: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab with Greek suufix
Current Sponsor code: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Biogen Idec Ltd.Not RecruitingFemale: yes
Male: yes
600Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India
975EUCTR2008-004753-14-BE22/01/200930 April 2018Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple SclerosisA Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ENDORSERelapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dimethyl Fumarate
CAS Number: 624497
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Biogen Idec LimitedAuthorisedFemale: yes
Male: yes
1738Phase 3Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
976EUCTR2008-003098-42-CZ06/01/200919 March 2012A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple SclerosisA Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple SclerosisTo evaluate the immunogenicity of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: AVONEX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: interferon beta 1a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
Biogen Idec LtdAuthorisedFemale: yes
Male: yes
150Czech Republic
977EUCTR2007-004223-38-GB05/01/200912 June 2012A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patientsA double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patientsRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Product Name: Ofatumumab
Product Code: HuMax-CD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ofatumumab
CAS Number: 679818-59-8
Current Sponsor code: HuMax-CD20
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
GlaxoSmithKline UKAuthorisedFemale: yes
Male: yes
57Germany;Czech Republic;United Kingdom;Denmark;Sweden
978NCT00666887January 200916 December 2017Minocycline in Clinically Isolated Syndromes (CIS)A Phase III Double-blind, Randomized, Placebo-controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS)Clinically Isolated Syndromes;Early Single Relapse of Multiple SclerosisDrug: Minocycline;Drug: PlaceboDr. Luanne MetzMultiple Sclerosis Society of CanadaNot recruiting18 Years60 YearsAll142Phase 3Canada
979NCT00828204January 200919 October 2017Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis SubjectsAn Open-Label, Multicenter Study to Evaluate the Safe and Effective Use of the Single-Use Autoinjector With an Avonex® Prefilled Syringe in Multiple Sclerosis SubjectsMultiple SclerosisDevice: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a)BiogenNot recruiting18 Years65 YearsAll95Phase 3United States
980NCT00841321January 200919 October 2017Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple SclerosisGinkgo Biloba for Cognitive Impairment in Multiple SclerosisMultiple Sclerosis;Cognitive Ability, GeneralDrug: Ginkgo biloba;Drug: PlaceboVA Office of Research and DevelopmentNot recruiting18 Years65 YearsAll120Phase 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
981NCT01031199January 200919 February 2015Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy VolunteersOpen-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 140 MBq (ca. 5 mSv) ZK 6032924 (BAY85-8101) for Its Diagnostic Potential in Either Drug-naïve or Specifically (IFN-beta) Pretreated Patients With Multiple Sclerosis (MS) With Acute Relapse or Patients With Clinically Isolated Syndrome (CIS), Compared to Healthy VolunteersPositron-Emission Tomography;Multiple SclerosisDrug: F-18 FEDAA1106 (BAY85-8101)BayerNot recruiting20 Years55 YearsBoth16Phase 1Australia;Sweden
982EUCTR2009-014724-32-DE3 April 2017Boswellic Acids in Multiple SclerosisSAFETY, TOLERABILITY AND MECHANISM OF ACTION OF BOSWELLIC ACIDS (BA) IN MULTIPLE SCLEROSIS (MS) AND CLINICALLY ISOLATED SYNDROME (CIS): A MRI-CONTROLLED, MULTICENTER, BASELINE-TO-TREATMENT, 32-WEEKS, OPEN-LABEL, PHASE IIA TRIAL IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS OR CLINICALLY ISOLATED SYNDROME - SABARelapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: BOSWELAN
Product Code: BOSWELAN
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: BOSWELAN
Current Sponsor code: BOSWELAN
Other descriptive name: Boswellia serrata extract PS0201Bo capsules
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
University Medical Center EppendorfNot RecruitingFemale: yes
Male: yes
Phase 2Germany
983EUCTR2009-016442-74-ES29 April 2013Trasplante autólogo de células madre mesenquimales en esclerosis múltiple: ensayo clínico fase II aleatorizado, enmascarado y cruzado con placebo.Trasplante autólogo de células madre mesenquimales en esclerosis múltiple: ensayo clínico fase II aleatorizado, enmascarado y cruzado con placebo.Esclerosis Múltiple
MedDRA version: 9 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
Product Name: Células madre mesenquimales
Pharmaceutical Form:
INN or Proposed INN: Células madre mesenquimales
Current Sponsor code: CMM
Concentration unit: EID50 50% Embryo Infective Dose
Concentration type: up to
Concentration number: 2000000-
Route of administration of the placebo: Intravenous use
Fundació Clínic per a la Recerca BiomèdicaAuthorisedFemale: yes
Male: yes
Spain
984NCT00725985December 31, 200816 December 2017Oral Cladribine in Early Multiple Sclerosis (MS)A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MSMultiple SclerosisDrug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF)EMD SeronoNot recruiting18 Years55 YearsAll617Phase 3United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Saudi Arabia
985EUCTR2008-005125-11-GB19/12/200819 March 2012A pilot single-centre randomised controlled trial of recombinant human erythropoietin versus placebo in primary progressive multiple sclerosis.A pilot single-centre randomised controlled trial of recombinant human erythropoietin versus placebo in primary progressive multiple sclerosis.Primary progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063401 Term: Primary progressive multiple sclerosis
Trade Name: Neorecormon
Product Name: Recombinant Human Erythropoietin
Product Code: rhEPO
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: epoetin beta
CAS Number: 122312-54-3
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 30000-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Walton Centre for Neurology and NeurosurgeryNot RecruitingFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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agemax
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size
PhaseCountries
986EUCTR2007-004051-11-GB18/12/200819 March 2012Amiloride Treatment in Multiple Sclerosis - Amiloride in MSAmiloride Treatment in Multiple Sclerosis - Amiloride in MSMultiple SclerosisTrade Name: Amiloride
Product Name: Amiloride Hydrochloride
Pharmaceutical Form: Coated tablet
Oxford Racliffe NHS TrustNot RecruitingFemale: yes
Male: yes
23United Kingdom
987EUCTR2008-004954-34-CZ12/12/200827 January 2014Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXIONSubjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
988NCT00819000December 200819 February 2015Therapy Optimization in Multiple Sclerosis (MS)TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty PharmaciesMultiple SclerosisDrug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1bTeva Neuroscience, Inc.Not recruiting18 YearsN/ABoth2878N/AUnited States
989NCT00819195December 200819 February 2015Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple SclerosisAnti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple SclerosisMultiple SclerosisDrug: Glatiramer acetateUniversity of California, San FranciscoNational Multiple Sclerosis Society;Teva Neuroscience, Inc.Not recruiting18 Years55 YearsBoth17N/AUnited States
990EUCTR2007-007759-15-HU10/11/200819 March 2012The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple Sclerosis A double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trialThe Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple Sclerosis A double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trialPatients with current diagnosis of SP-MS
MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Product Name: PI-2301
Product Code: CO-14
Pharmaceutical Form: Solution for injection
CAS Number: 1026791-33-1
Current Sponsor code: PI-2301
Other descriptive name: CO-14
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
PEPTIMMUNE IncNot RecruitingFemale: yes
Male: yes
53Hungary
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
991NCT00744679November 200819 February 2015A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady StateAn Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly InfusionsMultiple SclerosisDrug: NatalizumabBiogen IdecElan PharmaceuticalsNot recruiting18 Years55 YearsBoth20Phase 4United States
992NCT00771043November 200819 February 2015A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-aOptical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1aRelapsing-Remitting Multiple SclerosisDrug: TYSABRI and AVONEXBiogen IdecNot recruiting18 Years55 YearsBoth50Phase 4United States
993EUCTR2008-004579-22-AT14/10/200819 March 2012A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.Trade Name: Octagam 5%
Product Name: Octagam 5%
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Immunoglobulin
CAS Number: 9007-83-4
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-
Octapharma AGNot RecruitingFemale: yes
Male: yes
30Austria
994NCT00755807October 200819 October 2017Duloxetine for Multiple Sclerosis PainDuloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.Multiple SclerosisDrug: Duloxetine Hydrochloride (HCI);Drug: PlaceboEli Lilly and CompanyNot recruiting18 YearsN/AAll239Phase 3United States;Belgium;Canada;Poland
995NCT00784836October 200819 October 2017Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) PatientsA Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: BG9418 (interferon beta 1-a)BiogenNot recruiting18 Years60 YearsAll3Phase 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
996NCT01018485October 200825 May 2015The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) TremorDouble-Blind, Randomized, Controlled, Cross-over Comparison of Efficacy and Safety of Botulinum Toxin Type A in the Targeted Treatment of Disabling Tremor in Multiple SclerosisMultiple Sclerosis;TremorDrug: Botulinum Toxin Type AMelbourne HealthEastern HealthNot recruiting18 Years80 YearsBoth30Phase 3Australia
997NCT01080027October 200819 February 2015Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life SettingsMultiple Sclerosis, Relapsing RemittingDrug: Rebif® New FormulationMerck KGaAMerck A.E., Greece;Merck OY, Finland;Merck B.V., Netherlands;Merck A.B., Sweden;Merck, S.A., PortugalNot recruiting18 Years60 YearsBoth254N/AGreece
998EUCTR2008-002096-27-PL10/09/200819 March 2012A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/AA 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/ARelapsing-remitting multiple sclerosis.
MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
1080United Kingdom;Austria;Poland;Lithuania
999EUCTR2008-002560-34-BE02/09/200819 March 2012A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFRA Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFRCentral neuropathic pain due to Multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10054095 Term: Neuropathic pain
Trade Name: Cymbalta
Product Name: Duloxetine
Product Code: LY248686
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539594
Current Sponsor code: LY248686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Gastro-resistant capsule, hard
Route of administration of the placebo: Oral use
Eli Lilly and CompanyNot RecruitingFemale: yes
Male: yes
238Belgium
1000NCT00772525September 200819 February 2015Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple SclerosisA Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple SclerosisMultiple Sclerosis;Optic Nerve;NeuritisDrug: Nerispirdine (HP184);Drug: PlaceboSanofiNot recruiting18 YearsN/ABoth31Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
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PhaseCountries
1001NCT01184833September 200819 February 2015Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple SclerosisEvaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/ABoth852N/APoland
1002NCT01074346August 200819 February 2015Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple SclerosisA Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif®) Therapy for Korean Patients With Multiple SclerosisMultiple SclerosisDrug: Interferon-ß-1aMerck KGaANot recruitingN/AN/ABoth60N/AKorea, Republic of
1003NCT00676715July 31, 20087 October 2019A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple SclerosisPhase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMSMultiple Sclerosis, Relapsing-RemittingDrug: Placebo;Drug: Ocrelizumab;Drug: AvonexGenentech, Inc.Roche Pharma AGNot recruiting18 Years55 YearsAll220Phase 2United States;Belgium;Bulgaria;Canada;Czechia;Denmark;Finland;France;Germany;Italy;Mexico;Netherlands;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic
1004EUCTR2007-003997-24-GB08/07/200818 April 2012Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapsesLong-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapsesMultiple Sclerosis
MedDRA version: 12.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Product Name: Teriflunomide
Product Code: HMR 1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sanofi-Aventis recherche & développementNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
1005JPRN-UMIN0000027252008/07/012 April 2019Efficacy of ramatroban in multiple sclerosis patientsMultiple sclerosisAddition of ramatroban to conventional MS therapyIou hospitalNot RecruitingNot applicableNot applicableMale and Female5Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
1006NCT00645749July 200825 February 2019Helminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple SclerosisHelminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisBiological: Helminth ovaUniversity of Wisconsin, MadisonNational Multiple Sclerosis SocietyNot recruiting18 Years50 YearsAll17Phase 1United States
1007NCT00674141July 200819 February 2015Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) TreatmentNasal Administration of Dexamethasone for MS TreatmentMS Patient With Relpasing Remitting AttacksDrug: Dexamethasone soduim phosphateHadassah Medical OrganizationNot recruiting18 YearsN/ABoth10Phase 1Israel
1008NCT00726648July 200819 February 2015CDP323 Biomarker StudyDouble-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.Relapsing Multiple SclerosisDrug: CDP323;Drug: PlaceboUCB PharmaBiogen IdecNot recruiting18 Years65 YearsBoth71Phase 1/Phase 2United Kingdom
1009NCT00735007July 200819 October 201712-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.International, Multicenter, Single-arm, Open-label, 12-week Phase IIIb Study to Evaluate RebiSmart™ Suitability for Self Injection of Rebif® New Formulation (RNF) in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis (RMS)Multiple SclerosisDrug: Rebif® New Formulation (RNF) using RebiSmartTMEMD SeronoNot recruiting18 Years65 YearsAll106Phase 3United States;Canada;Germany;Italy;Spain;Sweden
1010EUCTR2007-001377-28-FR11/06/200819 March 2012Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILAdult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously, -- AND who developed adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder
MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic
MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis
MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome
MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative
MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis
MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis
MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia
MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis
MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Merck Serono International S.A.AuthorisedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
1011NCT03577977June 1, 200823 July 2018Betaferon Use in Children and Adolescents With Multiple SclerosisRetrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)BayerNot recruitingN/A18 YearsAll70Phase 1Russian Federation
1012NCT00716066June 20089 September 2019Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune DiseasesHigh-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic DiseasesAutoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis TransplantBiological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow TransplantationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)RecruitingN/A70 YearsAll40Phase 2United States
1013NCT00787657June 200826 October 2015Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon TreatmentBetaferon Prospective Study on Adherence, Coping and Nursing SupportRelapsing Remitting Multiple Sclerosis (RRMS)Drug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting12 YearsN/ABoth1723N/AArgentina;Bahrain;Belgium;Bosnia and Herzegovina;Canada;China;Colombia;Czech Republic;Egypt;Estonia;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Kuwait;Lebanon;Libyan Arab Jamahiriya;Mexico;Netherlands;New Zealand;Norway;Pakistan;Portugal;Saudi Arabia;Singapore;Slovakia;Slovenia;Sweden;Syrian Arab Republic;Taiwan;United Arab Emirates;United Kingdom;Venezuela
1014EUCTR2007-007394-22-GB22/05/200819 March 2012The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanningThe role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanningMultiple Sclerosis
MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
Trade Name: Tysabri
Product Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
Imperial College LondonAuthorisedFemale: yes
Male: yes
United Kingdom
1015EUCTR2007-000888-15-ES19/05/200819 March 2012ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO, PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DE METILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA EN PACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis MúltipleENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO, PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DE METILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA EN PACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis MúltiplePacientes afectos de esclerosis múltiple
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: SOLU-MODERIN 1 g
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 83432
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Trade Name: URBASON 40 mg comprimidos
Pharmaceutical Form: Tablet
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 83432
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
Servicio de NeurologíaAuthorisedFemale: yes
Male: yes
Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
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1016EUCTR2007-005362-12-FR13/05/200819 March 2012Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de l'IRM multimodale 3 tesla dans l'analyse des lésions de la SEP et leur progression. Etude longitudinale sur 3 ans. - USPIO-MitoxEtude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de l'IRM multimodale 3 tesla dans l'analyse des lésions de la SEP et leur progression. Etude longitudinale sur 3 ans. - USPIO-Mitox1. Multiple Sclerosis 2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis)
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
MedDRA version: 9.1 Level: LLT Classification code 10028246 Term: Multiple sclerosis aggravated
MedDRA version: 9.1 Level: LLT Classification code 10028247 Term: Multiple sclerosis like syndrome
MedDRA version: 9.1 Level: LLT Classification code 10028248 Term: Multiple sclerosis-like syndrome
MedDRA version: 9.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse
MedDRA version: 9.1 Level: LLT Classification code 10053395 Term: Progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063401 Term: Primary progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse
MedDRA version: 9.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Product Code: SH U 555 C
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: ZK 132 281
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
C.H.U. de RENNESAuthorisedFemale: yes
Male: yes
France
1017EUCTR2007-005363-10-FR13/05/200819 March 2012Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CISEtude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS1. Multiple Sclerosis 2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis)
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
MedDRA version: 9.1 Level: LLT Classification code 10028246 Term: Multiple sclerosis aggravated
MedDRA version: 9.1 Level: LLT Classification code 10028247 Term: Multiple sclerosis like syndrome
MedDRA version: 9.1 Level: LLT Classification code 10028248 Term: Multiple sclerosis-like syndrome
MedDRA version: 9.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse
MedDRA version: 9.1 Level: LLT Classification code 10053395 Term: Progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063401 Term: Primary progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse
MedDRA version: 9.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Product Code: SH U 555 C
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: ZK 132 281
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
C.H.U. de RENNESAuthorisedFemale: yes
Male: yes
France
1018EUCTR2007-006338-32-FR06/05/200818 September 2012Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosisPhase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosisRelapsing remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913/F03
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
Current Sponsor code: RO4964913/F03
Other descriptive name: RhuMab 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Avonex
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Hoffman La Roche LtdAuthorisedFemale: yes
Male: yes
200Phase 2Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy
1019NCT00640328May 200816 December 2017Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) PatientsA Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) PatientsMultiple SclerosisDrug: Ofatumumab 100;Drug: Ofatumumab 300;Drug: Ofatumumab 700;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years55 YearsAll38Phase 2Belgium;Czech Republic;Denmark;Former Serbia and Montenegro;Germany;Poland;Serbia;Sweden;United Kingdom
1020EUCTR2006-006299-39-NL23/04/200819 March 2012A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory ImpairmentA Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory ImpairmentPatients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment.
MedDRA version: 8.1 Level: LLT Classification code 10046543 Term: Urinary incontinence
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: 9060X
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum toxin type A
CAS Number: 93384-43-1
Current Sponsor code: AGN 191622
Other descriptive name: Botulinum toxin type A
Concentration type: equal
Concentration number: vials of 100-Allergan units
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intramuscular use
AllerganNot RecruitingFemale: yes
Male: yes
135Netherlands;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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size
PhaseCountries
1021EUCTR2008-001940-38-IT22/04/200819 March 2012Functional RMN study to evaluate the prompt and middle term effect of the treatment with Donepezil in patients affected by multiple sclerosis and mild impairment of cognitive function. - NDFunctional RMN study to evaluate the prompt and middle term effect of the treatment with Donepezil in patients affected by multiple sclerosis and mild impairment of cognitive function. - NDpatients affected by multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: ARICEPT
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Donepezil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: ARICEPT
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Donepezil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
OSPEDALE S. RAFFAELEAuthorisedFemale: yes
Male: yes
Italy
1022EUCTR2007-003086-40-FR08/04/200819 March 2012A Phase I/II Study of Pixantrone in Patients with an Aggressive Relapsing Remitting (RR) or Secondary Progressive (SP) Multiple Sclerosis (PIXAMS)A Phase I/II Study of Pixantrone in Patients with an Aggressive Relapsing Remitting (RR) or Secondary Progressive (SP) Multiple Sclerosis (PIXAMS)aggressive relapsing remitting (RR) or secondary progressive (SP) multiple sclerosisProduct Name: Pixantrone
Product Code: BBR 2778
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Pixantrone
CAS Number: 144675-97-8
Current Sponsor code: BBR 2778
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Fondation Charcot StichtingAuthorisedFemale: yes
Male: yes
20Phase 1/2France
1023NCT00605215April 200819 February 2015BRAVO Study: Laquinimod Double Blind Placebo Controlled Study in RRMS Patients With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®)A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With RRMS to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded Design.Multiple SclerosisDrug: laquinimod;Drug: placebo;Drug: Interferon ß-1a (Avonex®)Teva Pharmaceutical IndustriesNot recruiting18 Years55 YearsBoth1331Phase 3United States;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Israel;Italy;Lithuania;Macedonia, The Former Yugoslav Republic of;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Latvia;Montenegro;Turkey
1024NCT00642902April 200819 October 2017A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment CourseRelapsing Multiple SclerosisDrug: Atacicept;Drug: Placebo matched to ataciceptEMD SeronoNot recruiting18 Years60 YearsAll255Phase 2United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
1025NCT00670449April 200819 October 2017An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple SclerosisAn Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: FingolimodNovartisMitsubishi Tanabe Pharma CorporationNot recruiting18 Years60 YearsAll143Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
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1026NCT01414816April 200819 February 2015Betaferon® Regulatory Post-Marketing SurveillanceBetaferon® Regulatory Post-Marketing SurveillanceMultiple Sclerosis;Clinically Isolated SystemDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting12 YearsN/ABoth355N/AKorea, Republic of
1027EUCTR2007-003936-50-ES10/03/200812 June 2012Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas. A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMSEstudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas. A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMSEsclerosis múltiple recidivante Relapsing multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: atacicept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 25-150
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Merck Serono International S.A.AuthorisedFemale: yes
Male: yes
332Phase 2United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden
1028EUCTR2007-002179-15-FR04/03/200819 March 2012Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASHEtude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASHMéthylprednisolone administrée aux patients et contrôles à la dose de 1g/j pendant 3 jours, comme prescrit habituellement dans le cadre de leur pathologie.
MedDRA version: 8.1 Level: PT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Methylprednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)AuthorisedFemale: yes
Male: yes
France
1029NCT00429442March 200819 February 2015Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple SclerosisA Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in Patients Treated With Copaxone for at Least 3 MonthsRelapsing Remitting Multiple SclerosisDrug: Simvastatin;Drug: placeboAnna TsakiriSanofiNot recruiting18 Years60 YearsBoth0Phase 3Denmark
1030NCT00616733March 200819 February 201512-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis PatientsAn Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple SclerosisMultiple SclerosisDrug: CS-0777 tabletsDaiichi Sankyo Inc.Not recruiting18 Years65 YearsBoth25Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
1031NCT00638196March 200817 August 2015Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MSPhase II Study of Linoleic Acid in Relapsing Multiple SclerosisMultiple SclerosisDrug: Linoleic Acid/Oleic AcidUniversity of RochesterNot recruiting18 Years70 YearsBoth9Phase 1United States
1032EUCTR2008-000490-37-IT26/02/200810 December 2012Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - NDPharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - NDmultiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028053 Term: MS
Trade Name: EBIXA
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Memantine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Oral drops, solution
Route of administration of the placebo: Oral use
OSPEDALE S. RAFFAELENot RecruitingFemale: yes
Male: yes
Italy
1033EUCTR2005-002305-23-GB05/02/200819 March 2012A pilot study of combination monoclonal antibody treatment in early active relapsing-remitting multiple sclerosis using Campath-1H and its non-binding form, SM3. - SM3A pilot study of combination monoclonal antibody treatment in early active relapsing-remitting multiple sclerosis using Campath-1H and its non-binding form, SM3. - SM3Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Alemtuzumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
R&D Addenbrookes HospitalAuthorisedFemale: yes
Male: yes
United Kingdom
1034NCT00391352February 200819 February 2015fMRI Study of Treatment Recommendations Comparing Recently Diagnosed Multiple Sclerosis (MS) Patients to ControlsA Phase 4, fMRI Study of Treatment Recommendations Comparing Patients Taking IFN-ß-1a 44 mcg Tiw SC (Rebif®) to Controls of Patients Recently Diagnosed With Relapsing Remitting Multiple Sclerosis Currently Naive to Disease-Modifying Therapy.Relapsing-Remitting Multiple SclerosisDrug: IFN-ß-1a (Rebif®)Waukesha Memorial HospitalThe Cleveland ClinicNot recruiting18 Years65 YearsBoth21Phase 4United States
1035NCT00630383February 200819 February 2015Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis.Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis.Multiple SclerosisBiological: Live Hookworm Larvae;Other: HistamineUniversity of NottinghamNot recruiting18 Years60 YearsBoth0Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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Inclusion_
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PhaseCountries
1036EUCTR2007-004122-24-SE23/01/200816 October 2012An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Pharmaceutical Form: Capsule*
INN or Proposed INN: fingolimod hydrochloride
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Novartis Pharma AGNot RecruitingFemale: yes
Male: yes
1250Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden
1037EUCTR2007-006268-32-IT23/01/200819 March 2012EFFICACY AND SAFETYOF BOTULINUM TOXIN THERAPY ON UPPER LIMB SPASTICITY IN INFLAMMATORY AND DEMIELINIZZATING DISEASE OF CENTRAL NERVOUS SYSTEM. - NDEFFICACY AND SAFETYOF BOTULINUM TOXIN THERAPY ON UPPER LIMB SPASTICITY IN INFLAMMATORY AND DEMIELINIZZATING DISEASE OF CENTRAL NERVOUS SYSTEM. - NDmultiple sclerosis
MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
Trade Name: xeomin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: xeomin
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
OSPEDALE S. RAFFAELEAuthorisedFemale: yes
Male: yes
Italy
1038EUCTR2006-006872-39-GB04/01/200819 March 2012A randomised, double-blind, placebo controlled study of AIMSPRO in Multiple Sclerosis - AIMSPRO in MS bladder functionA randomised, double-blind, placebo controlled study of AIMSPRO in Multiple Sclerosis - AIMSPRO in MS bladder functionOveractive Bladder in Secondary Progressive Multiple Sclerosis and the other neurological symptoms associated with Secondary Progressive Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
MedDRA version: 9.1 Level: LLT Classification code 10012547 Term: Detrusor hyperreflexia
Product Name: AIMSPRO
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Daval International LimitedAuthorisedFemale: yes
Male: yes
United Kingdom
1039NCT00464958January 200819 February 2015One Year Extension Study To Protocol C2/5/TZ:MS-05Long Term Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in Patients With Multiple Sclerosis - Open Label Extension StudySpasticity;Multiple SclerosisDrug: sublingual tizanidine 12 mgTeva GTCNot recruiting20 Years65 YearsBoth10Phase 1/Phase 2Israel
1040NCT00536120January 200819 October 2017The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple SclerosisA Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: BG00002 (natalizumab);Biological: keyhole limpet hemocyanin (KLH);Biological: tetanus diphtheria toxoid vaccine (Td)BiogenNot recruiting18 Years60 YearsAll60Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
1041NCT00612872January 200815 April 2019Evaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With PD or AD and in Healthy SubjectsEvaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With Parkinson Disease or Alzheimer Disease and in Healthy SubjectsParkinson Disease;Alzheimer Disease;Healthy Controls;Multiple SclerosisDrug: [123I]CLINDEInstitute for Neurodegenerative DisordersNot recruiting30 Years50 YearsAll46Phase 1United States
1042NCT00681538January 200819 October 2017A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)A Two-phase, Phase 3 Study of the Safety and Efficacy of Sativex, in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis: Phase A - Single-blind Response Assessment; Phase B - Double-blind, Randomised, Placebo Controlled, Parallel Group Study.Spasticity;Multiple SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll572Phase 3United Kingdom
1043NCT00785473January 200819 February 2015Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple SclerosisCan Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre StudyMultiple Sclerosis, OsteoporosisDietary Supplement: cholecalciferol;Dietary Supplement: calcium carbonateUniversity Hospital of North NorwayNot recruiting18 Years50 YearsBoth80Phase 4Norway
1044NCT00938366January 200819 October 2017Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis SubjectsAn Open-label, Cross Over Study, to Assess the Interactions of Pantoprazole (Proton Pump Inhibitor) With Oral Cladribine Administered in Subjects With Multiple SclerosisMultiple SclerosisDrug: Cladribine;Drug: PantoprazoleMerck KGaAMerck Serono S.A., GenevaNot recruiting18 Years65 YearsAll18Phase 1
1045EUCTR2008-000499-25-DE26 June 2012International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMSInternational, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMSRelapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: Rebif New Formulation 44mcg multidose cartridge
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: NA
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 88-
Merck Serono International S.A.Not RecruitingFemale: yes
Male: yes
100Phase 3bGermany;Spain;Italy;Sweden
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1046EUCTR2008-005213-22-DE11 April 2016SUPREMES - Sunphenon in progressive forms of multiple sclerosisSUPREMES - Sunphenon in progressive forms of multiple sclerosis - SUPREMESprimary and secondary progressive forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Sunphenon
Pharmaceutical Form: Capsule, hard
Other descriptive name: Sunphenon EGCg
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Charite Universitätsmedizin BerlinNot RecruitingFemale: yes
Male: yes
Germany
1047EUCTR2008-005773-35-IT2 October 2017AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SMAUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SMMULTIPLE SCLEROSIS
MedDRA version: 15.1 Level: LLT Classification code 10028053 Term: MS System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: ENDOXAN BAXTER
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg/kg milligram(s)/kilogram
Concentration number: 40-
Trade Name: FLUDARA
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Fludarabine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration number: 30-
Trade Name: THYMOGLOBULINE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Antithymocyte immunoglobulin (rabbit)
Concentration unit: mg/kg milligram(s)/kilogram
Concentration number: 2.5-
Trade Name: MABTHERA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg/m2 milligram(s)/square meter
Concentration number: 375.5-
AZIENDA OSPEDALIERA DI PADOVANot AvailableFemale: yes
Male: yes
Phase 1Italy
1048EUCTR2008-007015-32-DE11 March 2013A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phaseA 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phasecognitive impairment in Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Exelon transdermales Pflaster
Product Name: Exelon
Product Code: ENA713
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rivastigmin
CAS Number: 123441-03-2
Current Sponsor code: ENA713
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use
Trade Name: Exelon transdermales Pflaster
Product Name: Exelon
Product Code: ENA713
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rivastigmin
CAS Number: 123441-03-2
Current Sponsor code: ENA713
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use
Trade Name: Exelon transdermales Pflaster
Product Name: Exelon
Product Code: ENA713
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rivastigmin
CAS Number: 123441-03-2
Current Sponsor code: ENA713
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Trade Name: Exelon transdermales Pflaster
Product Name: Exelon
Product Code: ENA713
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rivastigmin
CAS Number: 123441-03-2
Current Sponsor code: ENA713
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Novartis Pharma GmbHNot RecruitingFemale: yes
Male: yes
Germany
1049EUCTR2008-008719-25-DE1 May 2012A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosisA phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosisRelapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: BAF312
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
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
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Finland;Germany;Spain;Italy
1050EUCTR2007-001162-32-GB24/12/200726 June 2012A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIRelapsing Remitting Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Alemtuzumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Genzyme CorporationAuthorisedFemale: yes
Male: yes
573Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1051EUCTR2007-000586-38-IT21/12/200723 September 2013HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - NDHIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - NDPATIENTS AFFECTED BY MULTIPLE SCLEROSIS
MedDRA version: 6.1 Level: HLT Classification code 10052785
Trade Name: THIOPLEX
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Thiotepa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: ENDOXAN BAXTER
Pharmaceutical Form: Tablet
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: NEUPOGEN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Filgrastim
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
OSPEDALE S. RAFFAELENot RecruitingFemale: yes
Male: yes
Italy
1052EUCTR2007-005414-40-IT21/12/20073 April 2012Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - NDEfficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - NDPatients with an established and stable Multiple Sclerosis (according to Poser criteria).
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: KEPPRA
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Levetiracetam
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
AZIENDA SANITARIA N. 3 GENOVESEAuthorisedFemale: yes
Male: yes
Italy
1053EUCTR2007-001958-99-FI18/12/200719 March 2012Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MSCollecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MSPatients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion.
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: Dekristol 20000 IE
Product Name: Dekristol
Pharmaceutical Form: Capsule*
INN or Proposed INN: INN COLECALCIFEROL
Product Name: Placebo Dekristol SGC 20000
Pharmaceutical Form: Capsule*
Merja Soilu HäninenNot RecruitingFemale: yes
Male: yes
Finland
1054EUCTR2007-001962-34-DE12/12/20071 February 2016Klassische Konditionierung immunologischer Reaktionen bei Patienten mit Multipler Sklerose während Mitoxantrontherapie - MIMIKKlassische Konditionierung immunologischer Reaktionen bei Patienten mit Multipler Sklerose während Mitoxantrontherapie - MIMIKsecondary progressive multiple sclerosisTrade Name: Ralenova
Pharmaceutical Form: Solution for injection
INN or Proposed INN: mitoxantrone
Current Sponsor code: Mitox
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous drip use (Noncurrent)
University Medical Center Hamburg EppendorfNot RecruitingFemale: yes
Male: yes
5Germany
1055NCT00573443December 200716 December 2017Safety and Efficacy of AVP-923 in PBA Patients With ALS or MSA Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)Pseudobulbar Affect (PBA)Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: PlaceboAvanir PharmaceuticalsINC ResearchNot recruiting18 Years80 YearsAll326Phase 3United States;Argentina;Brazil
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1056NCT00623415December 200711 June 2018Flupirtine as Oral Treatment in Multiple SclerosisMulticentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-ß1b on Neurodegeneration in Patients With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Flupirtine;Drug: PlaceboCharite University, Berlin, GermanyBayerNot recruiting18 Years60 YearsAll30Phase 2Germany
1057EUCTR2007-000381-20-FI16/11/200725 September 2012CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSIONRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: CLADRIBINE
CAS Number: 4291638
Current Sponsor code: EMD280922
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
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
Merck Serono S.A. - GenevaNot RecruitingFemale: yes
Male: yes
1100Phase 3bGermany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
1058NCT00595920November 200719 October 2017Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple SclerosisAn Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated SyndromeBiological: TovaxinOpexa Therapeutics, Inc.Not recruitingN/AN/AAll116Phase 2United States
1059NCT00688948November 200719 February 2015Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple SclerosisMultiple Sclerosis;Bladder DysfunctionDrug: AlfuzosinCapital District Health Authority, CanadaSanofiNot recruiting18 YearsN/ABoth20Phase 2/Phase 3Canada
1060NCT00702468November 200719 October 2017Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple SclerosisA Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-term Sativex®.Spasticity;Multiple SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll36Phase 3United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1061NCT00937677November 200719 February 2015Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) StudyEffect of Natalizumab (Tysabri®) on Remyelination in Patients With Relapsing-remitting Multiple Sclerosis. A Follow-up Voxel-wise Magnetization Transfer Imaging Study.Multiple SclerosisDrug: TysabriUniversity at BuffaloBiogen IdecNot recruiting18 Years65 YearsBoth85N/AUnited States
1062EUCTR2008-007162-32-IT30/10/200719 March 2012ADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSMADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSMMultiple Sclerosis
MedDRA version: 9.1 Level: SOC Classification code 10029205 Term: Nervous system disorders
Trade Name: COPAXONE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: AVONEX
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: Munit million units
Concentration type: equal
Concentration number: 6-
ISTITUTO C. MONDINOAuthorisedFemale: yes
Male: yes
Italy
1063EUCTR2006-001152-12-CZ15/10/200720 February 2017An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period.An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period.Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
sanofi-aventis recherche & développementNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany
1064NCT00104143October 20075 September 2016A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis.Multiple SclerosisDrug: A4I AntagonistHoffmann-La RocheNot recruiting18 Years59 YearsBoth0Phase 2Bulgaria;Canada;Czech Republic;Germany;Poland;Russian Federation;Slovakia;Spain;United Kingdom;Finland;United States
1065NCT00548405October 200716 December 2017Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study TwoA Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On TherapyMultiple Sclerosis, Relapsing-RemittingBiological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg;Biological: Interferon beta-1aGenzyme, a Sanofi CompanyBayerNot recruiting18 Years55 YearsAll840Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czech Republic;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1066NCT00559702October 200719 February 2015Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: natalizumab;Other: standard of careBiogen IdecElan PharmaceuticalsNot recruiting18 Years65 YearsBoth76Phase 1United States
1067NCT00873340October 200719 February 2015Physical Disability in Patients Treated With BetaferonPhysical Disability Observational Study in Patients Treated With Betaferon in Daily PracticeMultiple SclerosisDrug: Interferon-1beta (Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/ABoth83N/AColombia
1068EUCTR2006-001337-17-DE25/09/200729 May 2012Characterisation of multiple sclerosis pathology by “ultra small particles of iron oxide (USPIO)” in comparison with conventional and advanced MRI imaging techniques [Charakterisierung der Multiple Sklerose Pathologie durch “ultra small particles of iron oxide (USPIO)” im Vergleich zu konventionellen und fortgeschrittenen MRT Techniken] - MS_USPIO_MPIPCharacterisation of multiple sclerosis pathology by “ultra small particles of iron oxide (USPIO)” in comparison with conventional and advanced MRI imaging techniques [Charakterisierung der Multiple Sklerose Pathologie durch “ultra small particles of iron oxide (USPIO)” im Vergleich zu konventionellen und fortgeschrittenen MRT Techniken] - MS_USPIO_MPIPPatients with Multiple Sclerosis (MS, N=90) and patients with a clinically isolated syndrome (ref. to as CIS in literature, i. e. not a clinically definite MS but a syndrome that may occur as first sign of MS early in the course, N=15) are planned to be investigated in the proposed clinical trial.
MedDRA version: 8.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Product Name: ultra small particles of iron oxide (USPIO)
Product Code: SH U 555 C
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: SH U 555 C
CAS Number: V08CB03
Current Sponsor code: USPIO
Other descriptive name: Ultrasmall particles of iron oxide
Concentration unit: mmol millimole(s)
Concentration type: equal
Concentration number: 0.5-
Max-Planck-Institute of PsychiatryAuthorisedFemale: yes
Male: yes
Germany
1069EUCTR2007-001031-63-CZ20/09/200712 December 2016AV650-018: A two-part (double-blind followed by open-label), placebo-controlled, randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis.AV650-018: A two-part (double-blind followed by open-label), placebo-controlled, randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis.Spasticity associated with multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028335 Term: Muscle spasticity
Trade Name: Tolposan
Product Code: AV605
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tolperisone HC1
CAS Number: 728-88-1
Other descriptive name: Tolpersan
Concentration unit: mg milligram(s)
Concentration type: range
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Avigen IncNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Germany
1070EUCTR2007-002138-13-GB13/09/200719 March 2012A placebo controlled, parallel group, randomised withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term GW-1000-02 (Sativex®).A placebo controlled, parallel group, randomised withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term GW-1000-02 (Sativex®).Symptoms of spasticity in multiple sclerosis.Trade Name: Sativex
Product Name: Sativex
Product Code: GW-1000-02
Pharmaceutical Form: Oromucosal spray
CAS Number: 1972-08-3
Other descriptive name: delta-9-tetrahydrocannabinol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 27-
CAS Number: 13956-29-1
Other descriptive name: Cannabidiol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Oromucosal use
GW Pharma Ltd.Not RecruitingFemale: yes
Male: yes
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
1071EUCTR2006-003037-32-LT11/09/200719 March 2012A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0 Level: PT Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon-beta 1a
CAS Number: NA
Current Sponsor code: Not applicable
Other descriptive name: Not applicable
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Merck Serono International SANot RecruitingFemale: yes
Male: yes
150Phase 3bGermany;Estonia;Spain;Italy;Lithuania
1072EUCTR2006-006347-31-GB06/09/200719 March 2012A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosisA Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosisMultiple Sclerosis
MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
Product Name: Encapsulated Simvastatin tablets
Product Code: MSTC-001 (MS-STAT)
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Imperial College LondonAuthorisedFemale: yes
Male: yes
Phase 2United Kingdom
1073EUCTR2007-003226-19-NL05/09/200719 March 2012Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroRelapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1 Level: PT Classification code 10028245 Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
Pharmaceutical Form: Capsule*
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: ABR-215062 sodium salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Teva Pharmaceutical Industries LtdNot RecruitingFemale: yes
Male: yes
1419Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
1074NCT00532532September 200719 February 2015Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple SclerosisAV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple SclerosisMuscle SpasticityDrug: tolperisone HClAvigenNot recruiting18 Years70 YearsBoth150Phase 2Czech Republic;Germany;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro
1075NCT00537082September 200719 October 2017Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: FTY720;Drug: PlaceboNovartisMitsubishi Tanabe Pharma CorporationNot recruiting18 Years60 YearsAll171Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
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PhaseCountries
1076NCT00544037September 200719 February 2015BENEFIT Extension StudyExtension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting23 Years50 YearsBoth283N/AAustria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Slovenia;Spain;Sweden;Switzerland;Portugal;United Kingdom
1077NCT00638833September 200719 February 2015Memantine Therapy for Multiple SclerosisPilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple SclerosisMultiple SclerosisDrug: Memantine;Drug: PlaceboClinica Universidad de Navarra, Universidad de NavarraH. Lundbeck A/SNot recruiting18 Years65 YearsBoth20Phase 2Spain
1078NCT00937157September 200719 October 2017Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI StudyMultiple SclerosisDrug: CopaxoneUniversity at BuffaloTeva Neuroscience, Inc.Not recruiting18 Years65 YearsAll12N/AUnited States
1079NCT02523703September 200724 August 2015Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot StudyMultiple SclerosisBiological: glutamate and aspartateUniversity Hospital, CaenNot recruiting18 Years60 YearsBoth36N/A
1080EUCTR2006-005910-11-CZ29/08/20075 December 2016A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study.A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study.Spacticity in multiple sclerosis (MS)Product Name: Sativex
Product Code: GW-1000-02
Pharmaceutical Form: Oromucosal spray
CAS Number: 1972-08-3
Other descriptive name: delta-9-tetrahydrocannabinol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 27-
CAS Number: 13956-29-1
Other descriptive name: Cannabidiol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Oromucosal use
GW Pharma LtdNot RecruitingFemale: yes
Male: yes
488Phase 3Czech Republic;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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size
PhaseCountries
1081EUCTR2007-001161-14-GB24/08/200712 June 2012A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-IA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-IRelapsing Remitting Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Alemtuzumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Genzyme CorporationNot RecruitingFemale: yes
Male: yes
525Phase 3Czech Republic;Germany;United Kingdom;France;Poland;Sweden
1082EUCTR2007-001031-63-DE15/08/200719 March 2012AV650-018: A two-part (double-blind followed by open-label), placebo-controlled, randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis.AV650-018: A two-part (double-blind followed by open-label), placebo-controlled, randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis.Spasticity associated with multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028335 Term: Muscle spasticity
Trade Name: Tolposan
Product Code: AV605
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tolperisone HC1
CAS Number: 728-88-1
Other descriptive name: Tolpersan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Avigen IncNot RecruitingFemale: yes
Male: yes
150Germany
1083NCT00530348August 200719 October 2017Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study OneA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: Alemtuzumab;Biological: Interferon beta-1aGenzyme, a Sanofi CompanyBayerNot recruiting18 Years50 YearsAll581Phase 3United States;Argentina;Australia;Brazil;Canada;Croatia;Czech Republic;France;Germany;Mexico;Poland;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom;Former Serbia and Montenegro
1084NCT00649792August 200719 October 2017Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 TrialPhase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 TrialMultiple SclerosisDrug: Fampridine-SRAcorda TherapeuticsNot recruiting18 Years70 YearsAll214Phase 3United States;Canada
1085NCT01235455August 200719 February 2015Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectorsPortuguese BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis (MS) After Conversion to Betaferon by Using Elements of the BetaPlus ProgramRelapsing Remitting Multiple Sclerosis (RRMS);Secondary Progressive Multiple Sclerosis (SPMS)Drug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/ABoth10N/APortugal
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
1086EUCTR2006-004893-29-GB25/07/20071 May 2012A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosisA randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosisMultiple sclerosisProduct Name: teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
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
Sanofi-aventis U.S. Inc.AuthorisedFemale: yes
Male: yes
120Germany;United Kingdom;Italy;Austria
1087EUCTR2007-000590-37-FR17/07/200719 March 2012Etude randomisée, en double aveugle, comparant l’efficacité et la tolérance de la méthylprednisolone administrée à forte dose par voie orale ou par voie intraveineuse dans le traitement des poussées de sclérose en plaques - COPOUSEPEtude randomisée, en double aveugle, comparant l’efficacité et la tolérance de la méthylprednisolone administrée à forte dose par voie orale ou par voie intraveineuse dans le traitement des poussées de sclérose en plaques - COPOUSEPTraitement des poussées de sclérose en plaques
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Product Name: METHYLPREDNISOLONE
Pharmaceutical Form: Capsule*
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 83432
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
Trade Name: methylprednisolone
Product Name: methylprednisolone
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: methylprednisolone
Product Name: methylprednisolone
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
CHU RennesAuthorisedFemale: yes
Male: yes
France
1088EUCTR2006-003697-10-BE13/07/200721 August 2017A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/ARelapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Pharmaceutical Form: Capsule, hard
CAS Number: 624497
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: Copaxone
Product Name: Copaxone
Pharmaceutical Form: Solution for injection
CAS Number: 147245929
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Biogen Idec Ltd.Not RecruitingFemale: yes
Male: yes
1232Phase 3Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;Latvia
1089EUCTR2004-000463-94-HU03/07/200719 March 2012A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).Relapsing-remitting multiple sclerosis (R-R MS)
MedDRA version: 5.1 Level: PT Classification code 10028245
Product Name: Glatiramer acetate 150mg enteric coated tablets
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Glatiramer Acetate
CAS Number: 147245-92-9
Current Sponsor code: COP-1
Other descriptive name: COP-1/Copolymer-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
TEVA Pharmaceutical Industries Ltd.Not RecruitingFemale: yes
Male: yes
25Hungary;Italy
1090NCT00467584July 200719 October 2017Aspirin for Treatment of Multiple Sclerosis-Related FatigueAspirin for Treatment of Multiple Sclerosis-Related FatigueMultiple Sclerosis;FatigueDrug: High Dose Aspirin (1300 mg/day);Drug: Low Dose Aspirin (162 mg/day);Drug: PlaceboMayo ClinicNational Multiple Sclerosis SocietyNot recruiting18 Years65 YearsAll62Phase 3United States
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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PhaseCountries
1091NCT00469378July 200716 December 2017Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple SclerosisAn Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With FirategrastMultiple SclerosisDrug: firategrastGlaxoSmithKlineNot recruiting18 Years65 YearsAll46Phase 2Belgium;Czech Republic;Denmark;Norway;Sweden
1092NCT00497952July 200728 January 2019Allogeneic Stem Cell Transplantation for the Treatment of Multiple SclerosisAllogeneic Stem Cell Transplantation for the Treatment of Multiple SclerosisMultiple SclerosisBiological: hematopoetic stem cell infusionUniversity of LouisvilleNot recruiting18 Years55 YearsAll3Phase 1/Phase 2United States
1093NCT00619307July 200719 October 2017Transition to Rebif New FormulationA Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as ProphylaxisRelapsing Multiple SclerosisDrug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRNMerck KGaANot recruiting18 Years60 YearsAll117Phase 3France;Germany
1094NCT01158183July 200719 February 2015Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple SclerosisReal-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon ß-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: BAY86-5046_Interferon-beta-1bBayerNot recruiting18 Years65 YearsBoth226N/AUnited States
1095EUCTR2004-002571-16-GB29/06/20074 August 2015A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01Secondary progressive multiple sclerosis
MedDRA version: 8.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Product Name: MBP8298 Synthetic Peptide
Product Code: MBP8298
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Dirucotide acetate
CAS Number: 781666-30-6
Current Sponsor code: MBP8298
Other descriptive name: MBP8298 Synthetic Peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
BioMS Technology CorpNot RecruitingFemale: yes
Male: yes
553Estonia;Finland;Spain;Lithuania;Denmark;Latvia;Netherlands;United Kingdom;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
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Target_
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PhaseCountries
1096NCT00493298June 29, 200730 September 2019Tysabri Observational ProgramTOP: Tysabri® Observational ProgramRelapsing-Remitting Multiple SclerosisDrug: natalizumabBiogenNot recruiting18 Years65 YearsAll6620Phase 4Argentina;Australia;Belgium;Brazil;Canada;Czechia;Finland;France;Germany;Greece;Italy;Mexico;Netherlands;Norway;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Denmark;Switzerland
1097EUCTR2006-006323-39-DE19/06/200719 March 2012Sunphenon (Epigallocatechin-Gallate) in relapsing-remitting multiple sclerosis - Sunphenon in RR-MSSunphenon (Epigallocatechin-Gallate) in relapsing-remitting multiple sclerosis - Sunphenon in RR-MSrelapsing-remitting multiple sclerosis ICD classification: G35.1Product Name: Sunphenon
Pharmaceutical Form: Capsule, hard
Other descriptive name: Sunphenon EGCg TM
Concentration unit: mg milligram(s)
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Charité-Universitätsmedizin BerlinNot RecruitingFemale: yes
Male: yes
100Germany
1098EUCTR2006-005972-42-FR12/06/200719 March 2012A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNFA randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNFRelapsing multiple sclerosis
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Trade Name: NA
Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF
Product Code: NA
Pharmaceutical Form: Solution for injection
Merck Serono International SAAuthorisedFemale: yes
Male: yes
120Phase 3bGermany;France
1099EUCTR2006-003134-14-DE04/06/200719 March 2012A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosisA randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosisMultiple sclerosisProduct Name: teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
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: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
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
Sanofi-aventis U.S. Inc.Not RecruitingFemale: yes
Male: yes
120Germany;Spain;Italy
1100NCT00468611June 200719 February 2015Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple SclerosisA Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple SclerosisMultiple Sclerosis, Secondary ProgressiveDrug: MBP8298BioMS Technology Corp.Not recruiting18 Years65 YearsBoth510Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
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Inclusion_
gender
Target_
size
PhaseCountries
1101NCT00480181June 200719 February 2015Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple SclerosisA Comparative, Single Center, Randomized, Double-blinded, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Nabilone (Cesamet) as Adjunctive Therapy to Gabapentin (Neurontin) in the Management of Neuropathic Pain (NPP) Symptoms in Subjects With Multiple Sclerosis (MS)Neuropathic Pain;Multiple SclerosisDrug: nabilone;Other: placeboUniversity of ManitobaValeant Pharmaceuticals International, Inc.Not recruiting18 Years65 YearsBoth50Phase 4Canada
1102NCT00490906June 200719 February 2015Comparison of Bone Effects With Copaxone and Interferon in Multiple SclerosisComparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot StudyMultiple Sclerosis;Low Bone DensityDrug: Copaxone;Drug: Interferon-beta 1a;Drug: Interferon-beta 1bNancy Hammond, MDKansas City Area Life Sciences Institute, Inc.Not recruiting18 YearsN/AFemale60N/AUnited States
1103NCT00574041June 200719 February 2015How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full DoseAn Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)Relapsing Remitting Multiple SclerosisDrug: Interferon beta-1aBiogen IdecNot recruiting18 YearsN/ABoth19Phase 4Australia
1104NCT00959218June 200719 February 2015Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple SclerosisMulti-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic PainCentral Neuropathic Pain in Multiple SclerosisDrug: Dronabinol;Drug: PlaceboBionorica Research GmbHNot recruiting18 Years70 YearsBoth240Phase 3Germany
1105EUCTR2006-005262-39-DE30/05/200711 February 2013Flupirtin as Oral Treatment in MS - FLORIMSFlupirtin as Oral Treatment in MS - FLORIMSRelapsing-remitting multiple sclerosisTrade Name: Trancopal Dolo
Product Name: Flupirtin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Flupirtin
CAS Number: 56995-20-1
Other descriptive name: Flupirtinmaleat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Charité-Universitätsmedizin BerlinNot RecruitingFemale: yes
Male: yes
Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
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Inclusion_
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Target_
size
PhaseCountries
1106EUCTR2006-007057-42-BE29/05/200728 October 2013An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastrelapsing forms of multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Pharmaceutical Form: Tablet
CAS Number: 402567-16-2
Current Sponsor code: SB-683699
Other descriptive name: firategrast (USAN approved name)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes
45Czech Republic;Belgium;Denmark;Sweden
1107EUCTR2007-000236-16-EE28/05/200719 March 2012A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple SclerosisA Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple SclerosisEstablished Spasticity Resulting from Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10041416 Term: Spasticity
Product Code: IPX056-40 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: BACLOFEN
CAS Number: 1134470
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Code: IPX056-35 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: BACLOFEN
CAS Number: 1134470
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-
Product Code: IPX056-30 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: BACLOFEN
CAS Number: 1134470
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Product Code: IPX056-20 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: BACLOFEN
CAS Number: 1134470
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
Product Code: IPX056-10 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: BACLOFEN
CAS Number: 1134470
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: baclofen
Product Name: baclofen
Product Code: baclofen 20 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: BACLOFEN
CAS Number: 1134470
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
IMPAX Laboratories, Inc.Not RecruitingFemale: yes
Male: yes
180Estonia;Latvia
1108EUCTR2006-005460-30-IT22/05/200719 March 2012POPART?MUS Prevention of Post Partum Relapses with Progestin and Estradiol in Multiple sclerosis - POPART`MUSPOPART?MUS Prevention of Post Partum Relapses with Progestin and Estradiol in Multiple sclerosis - POPART`MUSMultiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: DEMESTRIL SEPTEM
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Estradiol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .075-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use
Trade Name: LUTENYL
Pharmaceutical Form: Tablet
INN or Proposed INN: Nomegestrol
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
OSPEDALI CIVILI DI LIONEAuthorisedFemale: yes
Male: no
300Italy
1109NCT00461396May 200719 February 2015Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With BetaseronOpen-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 MonthsMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Interferon-1beta (Betaseron, BAY86-5046)BayerNot recruiting18 Years50 YearsBoth104N/AUnited States
1110NCT00483652May 200719 October 2017Study of Fampridine-SR Tablets in Multiple Sclerosis PatientsDouble-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple SclerosisMultiple SclerosisDrug: Fampridine-SR;Drug: PlaceboAcorda TherapeuticsNot recruiting18 Years70 YearsAll240Phase 3United States;Canada
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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PhaseCountries
1111NCT00928967May 200719 October 2015Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis PatientsProspective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMSMultiple SclerosisDrug: Interferon beta-1b, (Betaseron BAY86-5046)BayerNot recruiting18 YearsN/ABoth67N/AFrance
1112EUCTR2008-000955-90-IT24/04/200719 March 2012Randomized, single-blind, clinical and MRI study for evaluation of safety and efficacy of N-Acetyl Cysteine (NAC) associated with high-dose beta-Interferon in Relapsing-Remitting (RR) multiple sclerosis patients - renacRandomized, single-blind, clinical and MRI study for evaluation of safety and efficacy of N-Acetyl Cysteine (NAC) associated with high-dose beta-Interferon in Relapsing-Remitting (RR) multiple sclerosis patients - renacmultiple sclerosis
MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
Product Name: n-acetylcysteine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Acetylcysteine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
ISTITUTO C. MONDINOAuthorisedFemale: yes
Male: yes
Italy
1113EUCTR2006-005270-47-FI23/04/20071 May 2012International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-uprelapsing multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Betaferon 250µg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1b
CAS Number: L03 AB 08
Current Sponsor code: ZK 157046
Product Name: Betaferon 500µg
Product Code: ZK 157046
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1b
CAS Number: L03 AB 08
Current Sponsor code: ZK 157046
Schering AGAuthorisedFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
1114NCT00548769April 21, 200716 December 2017Firategrast (SB683699) Surface Area Study in Multiple Sclerosis PatientsAn Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple SclerosisMultiple SclerosisDrug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation DGlaxoSmithKlineNot recruiting18 Years65 YearsAll37Phase 1Czechia;Germany;Poland;Czech Republic
1115NCT00468182April 200725 May 2015Modulation of Plasmacytoid Dendritic Cell Function in Multiple SclerosisModulation of Plasmacytoid Dendritic Cell Function in Multiple SclerosisMultiple SclerosisDrug: Interferon-beta 1b (Betaseron)Rutgers, The State University of New JerseyBayerNot recruiting18 Years60 YearsBoth24Phase 4United States
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
1116NCT00472797April 200719 October 2017Rebif New Formulation (RNF) Quality of Life (QOL) StudyA Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)Relapsing Multiple SclerosisDrug: Rebif New Formulation Non Titrated;Drug: Rebif New Formulation TitratedEMD SeronoNot recruiting18 Years60 YearsAll232Phase 3United States
1117EUCTR2006-002204-33-BE02/03/20077 October 2014Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Relapsing forms of multiple slerosis
MedDRA version: 9.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse
Product Name: CDP323
Product Code: CDP323
Pharmaceutical Form: Capsule, hard
CAS Number: 455264-30-9
Current Sponsor code: CDP323
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
UCB Pharma S.A.Not RecruitingFemale: yes
Male: yes
317Phase 2France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden
1118EUCTR2006-003696-12-BE02/03/20079 October 2012A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/ARelapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Pharmaceutical Form: Capsule, hard
CAS Number: 624497
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 Ltd.Not RecruitingFemale: yes
Male: yes
1011Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden
1119NCT00451204March 200719 October 2017A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)A Combination Trial of Copaxone Plus Estriol in RRMSRelapsing Remitting Multiple SclerosisDrug: Estriol;Drug: Placebo;Drug: CopaxoneUniversity of California, Los AngelesWashington University School of Medicine;University of Texas Southwestern Medical Center;Ohio State University;University of Medicine and Dentistry of New Jersey;University of Chicago;University of Utah;Johns Hopkins University;University of Kansas Medical Center;University of Minnesota, MN;Mayo Clinic;University of Colorado, Aurora;University of New Mexico;University of Pennsylvania;Dartmouth-Hitchcock Medical Center;National Multiple Sclerosis Society;National Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years50 YearsFemale158Phase 2United States;Canada
1120NCT01111656March 200719 February 2015Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1bSWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study (SWABIMS Follow Up-study)Relapsing-remitting Multiple SclerosisDrug: Interferon beta-1b group;Drug: Interferon beta-1b/Atorvastatin groupUniversity Hospital Inselspital, BerneViollier AG, Basel, Switzerland;PharmaPart GmbH, Thalwil, SwitzerlandNot recruiting18 Years67 YearsBoth28Phase 2Switzerland
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
1121EUCTR2006-003384-30-SK26/02/200713 March 2017A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for Multiple SclerosisA Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for Multiple SclerosisMultiple SclerosisProduct Name: NeuroVax 300ug/mL Dose for IM Injection
Product Code: IR902
Pharmaceutical Form: Emulsion for injection
Current Sponsor code: IR208
Other descriptive name: VB6S5
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 75-125
Current Sponsor code: IR401
Other descriptive name: VB13S1
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 75-125
Current Sponsor code: IR901
Other descriptive name: VB5S2
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 75-125
Pharmaceutical form of the placebo: Emulsion for injection
Route of administration of the placebo: Intramuscular use
The Immune Response CorporationNot RecruitingFemale: yes
Male: yes
200Phase 2Slovakia
1122EUCTR2006-002856-14-DE21/02/200716 September 2013Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis.Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis.Secondary progressive or progressive relapsing multiple sclerosis with signs of disease activity in terms of inflammation
MedDRA version: 8.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Trade Name: Ovastat 1000
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: TREOSULFAN
CAS Number: 299752
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Ovastat 5000
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: TREOSULFAN
CAS Number: 299752
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5000-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
medac Gesellschaft für klinische Spezialpräparate mbHNot RecruitingFemale: yes
Male: yes
Phase 2Germany
1123EUCTR2007-000503-15-IT19/02/200719 March 2012Experimental clinical open study, randomized, experimental group vs control group, for the evaluation of tolerability and the effects on magnetic resonance parameters and cognitive functions of memantine in patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta. - NEMESI-MS Neuroprotection by Memantine at Early Stage In Multiple SclerosisExperimental clinical open study, randomized, experimental group vs control group, for the evaluation of tolerability and the effects on magnetic resonance parameters and cognitive functions of memantine in patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta. - NEMESI-MS Neuroprotection by Memantine at Early Stage In Multiple Sclerosispatients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta.
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: EBIXA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Memantine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
AZ. OSPEDALIERA GARIBALDI, S.LUIGI CURRO , ASCOLI TOMASELLIAuthorisedFemale: yes
Male: yes
Italy
1124NCT00501696February 200719 February 2015A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose NaltrexoneA Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone on Quality of Life as Measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI54)Multiple SclerosisDrug: 4.5 mg Naltrexone;Drug: NaltrexoneUniversity of California, San FranciscoNot recruiting18 Years86 YearsBoth80Phase 3United States
1125NCT00870155February 200719 February 2015A Study for Patients With Multiple SclerosisAn Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisDrug: dirucotideEli Lilly and CompanyBioMS Technology Corp.Not recruiting18 Years65 YearsBoth546Phase 2/Phase 3Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom
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
1126EUCTR2006-003361-14-GB23/01/200724 July 2012Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses -Multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Product Name: teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
sanofi-aventis recherche & développementAuthorisedFemale: yes
Male: yes
1080Portugal;Germany;Turkey;Switzerland;Netherlands;France;Norway;Italy;Austria;Sweden;Finland;Russian Federation;United Kingdom;Czech Republic;Ukraine;Canada;Denmark;Estonia;United States;Poland
1127EUCTR2006-004736-79-SK19/01/200713 March 2017A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis.A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis.To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo.Product Name: ATL1102
Product Code: ATL1102
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Antisense Therapeutics Ltd.Not RecruitingFemale: yes
Male: yes
80Phase 2Czech Republic;Slovakia
1128EUCTR2006-004255-38-AT05/01/200720 May 2013Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic painMulti-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic painPatients with multiple sclerosis associated with central neuropathic pain
MedDRA version: 16.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852
Product Name: dronabinol
Product Code: cnp-MS-0601
Pharmaceutical Form: Oral solution
INN or Proposed INN: dronabinol
CAS Number: 1972-08-3
Current Sponsor code: cnp-MS-0601
Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol
Concentration unit: % percent
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Bionorica research GmbHNot RecruitingFemale: yes
Male: yes
240Austria;Germany
1129NCT00414453January 200719 October 2017Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple SclerosisTrial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)Neuropathic Pain;Chronic Pain;Multiple SclerosisDrug: Lidocaine patch 5%;Drug: Extended-release oxycodone;Drug: Placebo extended-release oxycodone pills;Drug: Placebo lidocaine patchesUniversity of RochesterEndo PharmaceuticalsNot recruiting18 YearsN/AAll19Phase 4United States
1130NCT00423527January 200719 February 2015Levetiracetam in Central Pain in Multiple Sclerosis(MS)Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple SclerosisMultiple SclerosisDrug: levetiracetamOdense University HospitalNot recruiting18 YearsN/ABoth30Phase 4Denmark
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_
gender
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size
PhaseCountries
1131NCT00424788January 200719 February 2015A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)Relapsing Forms of Multiple SclerosisProcedure: Plasma exchange;Drug: natalizumab treatmentBiogen IdecNot recruiting18 Years50 YearsBoth12Phase 0United States
1132NCT00457730January 200719 October 2017A Study to Test the Use of Duloxetine for Pain in MSA Randomized Placebo Controlled Trial of Duloxetine for Central Pain in Multiple SclerosisMultiple SclerosisDrug: Duloxetine;Drug: PlaceboBrown, Theodore R., M.D., MPHEli Lilly and CompanyNot recruiting18 YearsN/AAll38Phase 2/Phase 3United States
1133EUCTR2006-004318-42-NL12/12/200619 March 2012Influence on brain perfusion and metabolism through pharmacologic agentsInfluence on brain perfusion and metabolism through pharmacologic agentsMultiple Sclerosis
MedDRA version: 8.1 Level: PT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Prepulsid
Pharmaceutical Form: Tablet
Trade Name: Spiropent
Pharmaceutical Form: Tablet
Department of Neurology UMCGAuthorisedFemale: yes
Male: yes
Netherlands
1134EUCTR2006-002361-39-DE01/12/200619 March 2012A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivityA 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivityNeurogenic overactive bladder disaese in patients with multiple sclerosis
MedDRA version: 8.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Trade Name: EMSELEX 7,5 mg Retardtabletten
Product Name: Darifenacin
Product Code: BAY 79-4998
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Darifenacin
Current Sponsor code: Bay 79-4998
Concentration unit: mg milligram(s)
Concentration type: equal
Trade Name: EMSELEX 15 mg Retardtabletten
Product Name: Darifenacin
Product Code: BAY 79-4998
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Darifenacin
Current Sponsor code: Bay 79-4998
Concentration unit: mg milligram(s)
Concentration type: equal
Bayer Vital GmbHNot RecruitingFemale: yes
Male: yes
Germany
1135NCT00358293December 200619 February 2015Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant SpasticityA Double-Blind, Randomized, Crossover Study to Evaluate the Clinical Efficacy and Safety of Oral Tizanidine HCl (12 mg) Versus Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in MS PatientsMuscle SpasticityDrug: Tizanidine (sublingual or oral)Teva GTCNot recruiting20 Years65 YearsBoth20Phase 1/Phase 2Israel
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1136NCT00395317December 200619 February 2015Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS)Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple SclerosisMultiple SclerosisOther: Placebo;Drug: Firategrast 150 mg;Drug: Firategrast 300 mgGlaxoSmithKlineNot recruiting18 Years65 YearsBoth343Phase 2Australia;Austria;Canada;Finland;France;Germany;Italy;Netherlands;New Zealand;Norway;Poland;Russian Federation;Spain;United Kingdom;Lithuania
1137NCT00411723December 200619 February 2015Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple SclerosisPhase 1 Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple SclerosisMultiple Sclerosis, Chronic Progressive;Multiple Sclerosis, Relapsing-RemittingDrug: RTL1000 (recombinant T cell receptor ligand);Drug: RTL1000 PlaceboArtielle ImmunoTherapeuticsNot recruiting18 Years65 YearsBoth34Phase 1United States
1138NCT00428584December 200619 October 2017RNF and Betaseron® Tolerability StudyA Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety ExtensionRelapsing Remitting Multiple Sclerosis (RRMS)Drug: New Formulation of rebif - human interferon beta-1a;Drug: Interferon beta -1bEMD SeronoPfizerNot recruiting18 Years60 YearsAll129Phase 3United States
1139NCT00594087December 200619 February 2015Eszopiclone for Improving Sleep in Multiple Sclerosis (MS)Eszopiclone for Improving Sleep Continuity in MS Patients With Sleep Disturbances and Its Impact on Daytime FatigueRelapsing Remitting Multiple Sclerosis;Sleep Initiation and Maintenance Disorders;FatigueDrug: eszopiclone;Other: placeboUniversity of VermontNot recruiting18 Years64 YearsBoth30N/AUnited States
1140EUCTR2006-002982-38-BE29/11/200621 August 2017A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0 Level: PT Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon-beta 1a
CAS Number: NA
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Merck Serono S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1141EUCTR2006-000606-23-ES23/11/200629 May 2012?Post-authorization safety study to check the potential association between the safety profile of beta interferon 1a and the body mass index or pharmacodynamics during the titration phasePost-authorization safety study to check the potential association between the safety profile of beta interferon 1a and the body mass index or pharmacodynamics during the titration phase - PASS-PD del escalado de dosis de RebifNot applicalbe
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif 22 y 44 mcg
Product Name: Interferon-beta-1a
Pharmaceutical Form: Solution for injection
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Merck, S.L.AuthorisedFemale: yes
Male: yes
Spain
1142EUCTR2006-002633-20-NL17/11/200618 April 2012Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Pharmaceutical Form: Tablet
CAS Number: 402567-16-2
Current Sponsor code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Firategrast
Product Code: SB683699
Pharmaceutical Form: Tablet
CAS Number: 402567-16-2
Current Sponsor code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
1143NCT00370071November 200619 October 2017Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple SclerosisOpen Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting16 Years55 YearsAll39Phase 3China
1144NCT00436826November 200619 October 2017A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-ß) Treatment in Multiple Sclerosis Subjects With Active DiseaseMultiple SclerosisDrug: Cladribine;Drug: Placebo;Drug: Interferon-beta (IFN-beta)EMD SeronoNot recruiting18 Years65 YearsAll214Phase 2United States;Italy;Russian Federation;Spain
1145NCT00529581November 200619 February 2015A Study of C105 on Cognitive Dysfunction in Persons With Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of C105 in Persons With Multiple Sclerosis With Cognitive ImpairmentCognition Disorders;Multiple SclerosisDrug: C105Cognition Pharmaceuticals, LLCNot recruiting18 Years65 YearsBoth150Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
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size
PhaseCountries
1146EUCTR2006-000704-17-GB19/10/20061 May 2012A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
Pharmaceutical Form: Capsule*
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Interferon beta-1a
Pharmaceutical Form: Solution for injection
INN or Proposed INN: interferon beta-1a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30/0.5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Product Code: FTY720
Pharmaceutical Form: Capsule*
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
1147NCT00516893October 200619 October 2017Natalizumab High Titer Immunogenicity and SafetyA Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: BG00002-E (natalizumab high titer)BiogenElan PharmaceuticalsNot recruiting18 Years55 YearsAll113Phase 2United States
1148NCT00781872October 200624 June 2019Mesenchymal Stem Cells for the Treatment of MSExplorative Trial to Investigate the Migration Ability of Mesenchymal Bone Marrow Stem Cells (MSC) in the Central Nervous System (CNS) Following Their Intrathecal Administration in Severe Cases of Multiple Sclerosis (MS)Multiple SclerosisBiological: injection of autologous stem cellsHadassah Medical OrganizationNot recruiting35 Years65 YearsAll20Phase 1/Phase 2
1149NCT01091727October 200619 February 2015Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor OveractivityProspective Randomized Double-blind Trial of Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity and Urinary Incontinence Related to Spinal Cord Injury or Multiple SclerosisNeurogenic Detrusor OveractivityDrug: Botulinum toxin ASunnybrook Health Sciences Centreethica Clinical Research Inc.Not recruiting18 Years75 YearsBoth57Phase 3Canada
1150EUCTR2006-001947-70-SK14/09/200613 March 2017A Double Blind, Placebo Controlled Multi-Center Pilot Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple SclerosisA Double Blind, Placebo Controlled Multi-Center Pilot Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisProduct Name: MBP8298 Synthetic Peptide
Product Code: MBP8298
Pharmaceutical Form: Powder for injection*
CAS Number: 781666-30-6
Current Sponsor code: MBP8298
Other descriptive name: MBP8298 Synthetic Peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
BioMS Technology Corp.Not RecruitingFemale: yes
Male: yes
215Phase 2Slovakia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1151EUCTR2004-001286-17-PT08/09/200619 March 2012Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosisExploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosisRelapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity
MedDRA version: 7.0 Level: PT Classification code 10028245
Product Name: Mitoxantrone
Product Code: N/A
Pharmaceutical Form: Solution for infusion
Fundación Española de Esclerosis Múltiple (FEDEM)AuthorisedFemale: yes
Male: yes
50Portugal
1152EUCTR2005-005751-18-GB07/09/20063 April 2012A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy StudyA multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy StudyMultiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.Trade Name: Rebif 44
Product Name: Rebif 44
Product Code: Interferon beta 1a
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta 1a
Current Sponsor code: IFNB-1a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 44-
Trade Name: Rebif 22
Product Name: Rebif 22
Product Code: Interferon beta 1a
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta 1a
Current Sponsor code: IFNB-1a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 22-
Product Name: Betaferon 500mcg
Product Code: Betaferon 500mcg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta 1b
Current Sponsor code: IFNB-1b
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 500-
UCL Biomedicine R&D UnitNot RecruitingFemale: yes
Male: yes
100United Kingdom
1153NCT00261326September 200619 February 2015Simvastatin Treatment of Patients With Acute Optic NeuritisSimvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III TrialOptic Neuritis;Multiple SclerosisDrug: simvastatin;Drug: placeboGlostrup University Hospital, CopenhagenAlpharma ApSNot recruiting18 Years59 YearsBoth64Phase 3Denmark
1154NCT00381264September 200619 February 2015Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple SclerosisA Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple SclerosisMultiple SclerosisDrug: Cesamet™ (nabilone)NEMA Research, Inc.Not recruiting18 Years75 YearsBoth23Phase 4United States
1155NCT00391079September 200619 October 2017Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MSA Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex When Added to the Existing Treatment Regimen, in the Relief of Central Neuropathic Pain in Subjects With Multiple SclerosisMultiple SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll339Phase 3Canada
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
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agemax
Inclusion_
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Target_
size
PhaseCountries
1156NCT00398528September 200619 February 2015An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple SclerosisAn fMRI Study of Treatment Optimization Recommendations Comparing Patients Changing Treatment From Glatiramer Acetate 20 mg qd SC (Copaxone®) to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Those Changing From to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Glatiramer Acetate 20 mg qd SC (Copaxone®) in a Multicenter Study of Patients With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy.Relapsing-Remitting Multiple SclerosisDrug: Glatiramer acetate, (Copaxone®);Drug: IFN-ß-1a, (Avonex®)NeurognosticsNot recruiting18 Years65 YearsBoth48Phase 4United States
1157NCT00588393September 200619 February 2015FolateScan in Autoimmune DiseaseStudy of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory DiseasesRheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus ErythematosusDrug: FolateScan (Technetium Tc 99mEC20)Mayo ClinicEndocyteNot recruiting18 YearsN/ABoth75Phase 2United States
1158EUCTR2005-005985-35-NL29/08/200619 March 2012A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis.A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis.Relapsing forms of Multiple Sclerosis
MedDRA version: 8.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Code: BIRT 2584 XX
Pharmaceutical Form: Tablet
CAS Number: 688756-00-5
Current Sponsor code: BIRT 2584 XX
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: BIRT 2584 XX
Pharmaceutical Form: Tablet
CAS Number: 688756-00-5
Current Sponsor code: BIRT 2584 XX
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Boehringer IngelheimAuthorisedFemale: yes
Male: yes
320Czech Republic;Netherlands;Italy
1159EUCTR2006-001161-42-GB29/08/20063 July 2017Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECTMulticentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECTMultiple sclerosis (MS)
MedDRA version: 8.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Product Name: DACLIZUMAB HYP
Pharmaceutical Form: Solution for injection
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
600Phase 2Czech Republic;Hungary;Germany;United Kingdom;Sweden
1160EUCTR2006-003113-40-NL18/08/200619 March 2012Dexamethason for the treatment of exacerbations in multiple sclerosisDexamethason for the treatment of exacerbations in multiple sclerosisMultiple Sclerosis
MedDRA version: 8.1 Level: PT Classification code 10028245 Term: Multiple sclerosis
Product Name: Dexamethason
Pharmaceutical Form: Capsule*
INN or Proposed INN: Dexamethasone
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Department of Neurology UMCGAuthorisedFemale: yes
Male: yes
60Netherlands
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_
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size
PhaseCountries
1161EUCTR2006-004937-13-IT17/08/200619 March 2012multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trialmulticentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trialpatients with relapsing remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: AZATIOPRINA HEX. 50CPR 50MG BL
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: REBIF SC 12SIR 6000000UI 22MCG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Trade Name: BETAFERON SC 15F 0,25MG 15SIR
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1b
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 8-
Trade Name: REBIF SC 12SIR 12000000UI44MCG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Trade Name: AVONEX IM 4SIR 30MCG/0,5ML 4AG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Universita di FirenzeAuthorisedFemale: yes
Male: yes
Italy
1162NCT00337779August 200619 October 2017Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)Relapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate (GA) 40 mg;Drug: glatiramer acetate 20 mgTeva Pharmaceutical IndustriesNot recruiting18 Years55 YearsAll1155Phase 3Argentina;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain;United Kingdom;United States
1163NCT00618527August 200619 February 2015Combination Therapy Using Cellcept and Rebif in RRMSCombination Therapy Using Mycophenolate Mofetil (CellCept) and Human Interferon beta1a (Rebif) in Early Treatment of Multiple SclerosisMultiple SclerosisDrug: mycophenolate mofetil (Cellcept);Drug: human interferon beta 1a (Rebif)Aaron BosterEMD Serono;PfizerNot recruiting18 Years65 YearsBoth31Phase 0United States
1164NCT00882453August 200619 February 2015Physical Activity and Fatigue in Early Multiple Sclerosis (MS)Betaferon Treatment and Exercise Data Gathering IN Early MSMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/ABoth1739N/AAustralia;Austria;Bahrain;Belgium;Canada;Colombia;Czech Republic;Denmark;Egypt;France;Germany;Greece;Indonesia;Israel;Italy;Jordan;Kazakhstan;Korea, Republic of;Kuwait;Lebanon;Mexico;Netherlands;Norway;Oman;Portugal;Slovenia;Spain;Sweden;Switzerland;Taiwan;Thailand;United Arab Emirates;United Kingdom
1165EUCTR2005-005592-14-DE27/07/200629 May 2012Double blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision ProtectDouble blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision ProtectMultiple sclerosis (MS) is a chronic disease of the central nervous system.Optic neuritis represents one of the most common and frequently the first clinical manifestation of MS. Optic neuritis is mainly characterized by a subacute loss of vision.Trade Name: Erypo/Erypo FS
Product Name: Erypo/Erypo FS
Pharmaceutical Form: Injection*
INN or Proposed INN: Epoetin alfa
Other descriptive name: Epo
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: up to
Concentration number: 10000-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: Urbason solubile forte 1000mg
Product Name: Methylprednisolone
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Methylprednisolon-21-hydrogensuccinat, Natriumsalz
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 1000 mg-
IFSgGmbH, Institute for clinical researchNot RecruitingFemale: yes
Male: yes
Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
agemax
Inclusion_
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size
PhaseCountries
1166EUCTR2006-002037-20-HU27/07/200619 March 2012A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTERelapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1 Level: PT Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
CAS Number: 147245-92-9
Current Sponsor code: 40 mg GA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
CAS Number: 147245-92-9
Current Sponsor code: 20 mg GA
Other descriptive name: Copaxone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Teva Pharmaceutical Industries, Ltd.Not RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
1167NCT00288626July 200616 December 2017High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) StudyA Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: Granulocyte-colony stimulating factor (G-CSF) and prednisone;Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM);Procedure: Autologous hematopoietic stem cell transplantNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Not recruiting18 Years60 YearsAll25Phase 2United States
1168NCT00501943July 200619 October 2017Neuroprotection With Riluzole Patients With Early Multiple SclerosisNeuroprotection With Riluzole in Patients With Early Multiple SclerosisMultiple SclerosisDrug: Avonex (Interferon beta 1a);Drug: Riluzole;Drug: PlaceboUniversity of California, San FranciscoNational Multiple Sclerosis Society;Oregon Health and Science UniversityNot recruiting18 Years55 YearsAll43Phase 2United States
1169NCT00638027July 200619 October 2017Memantine for Spasticity in MS PatientsMemantine for Spasticity in MS PatientsMultiple SclerosisDrug: placebo;Drug: memantineUniversity of RochesterForest LaboratoriesNot recruiting18 Years70 YearsAll21Phase 4United States
1170NCT00644904July 200619 February 2015Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple SclerosisA Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple SclerosisMultiple SclerosisDietary Supplement: Vitamin D3University of TorontoDirect MS-Proactive Charity;Multiple Sclerosis Society of CanadaNot recruiting18 Years55 YearsBoth49Phase 1/Phase 2Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1171EUCTR2005-005679-13-IT28/06/200619 March 2012An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - NDAn open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - NDmultiple sclerosis
MedDRA version: 6.1 Level: PT Classification code 10053395
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Naltrexone
CAS Number: 16676-29-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
OSPEDALE S. RAFFAELEAuthorisedFemale: yes
Male: yes
40Italy
1172EUCTR2005-001567-55-DE23/06/200618 April 2012A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisA Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisThis study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation.Product Name: Daclizumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Protein Design Labs, Inc.Not RecruitingFemale: yes
Male: yes
270Phase 2United Kingdom;Germany;Spain
1173EUCTR2005-004061-41-GB01/06/200628 February 2019TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATAMultiple sclerosis (MS)
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI 300 mg concentrate for solution for infusion
Product Name: NATALIZUMAB
Product Code: BG00002
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Natalizumab
Current Sponsor code: BG00002
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
BIOGEN IDEC LTDNot Recruiting Female: yes
Male: yes
458Phase 3Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
1174NCT00342381June 200619 February 2015Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic StimulationFatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic StimulationMultiple Sclerosis;FatigueDrug: 3,4-diaminopyridine;Drug: PlaceboUniversity of AarhusThe Danish Multiple Sclerosis SocietyNot recruiting18 Years55 YearsBoth120Phase 2Denmark
1175NCT00355134June 200619 October 2017Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseMultiple SclerosisDrug: Fingolimod;Drug: PlaceboNovartisNot recruiting18 Years55 YearsAll1083Phase 3United States;Australia;Austria;Canada;Poland;Romania;Turkey;United Kingdom;Lithuania
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1176NCT00648908June 200619 October 2017Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 TrialPhase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 TrialMultiple SclerosisDrug: Fampridine-SRAcorda TherapeuticsNot recruiting18 Years70 YearsAll269Phase 3United States;Canada
1177EUCTR2006-000397-71-DK16/05/200619 March 2012Double-blind, randomised, placebo-controlled trial of levetiracetam for central neuropathic pain in patients with multiple sclerosis - levetiracetam for central neuropathic pain in patients with multiple sclerosisDouble-blind, randomised, placebo-controlled trial of levetiracetam for central neuropathic pain in patients with multiple sclerosis - levetiracetam for central neuropathic pain in patients with multiple sclerosisTrade Name: Keppra
Product Name: Levetiracetam
Product Code: ucb L059
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Søren H. Sindrup, Department of Neurology, Odense University HospitalNot RecruitingFemale: yes
Male: yes
30Denmark
1178NCT00245622May 200619 February 2015Autologous T Cell Vaccine (TCV) for Multiple SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MSRelapsing-Remitting Multiple SclerosisBiological: Tovaxin Autologous T cell vaccine;Biological: PlaceboOpexa Therapeutics, Inc.Not recruiting18 Years55 YearsBoth150Phase 2United States
1179NCT00324506May 200619 February 2015Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple SclerosisA Randomized, Open-label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: Mycophenolate Mofetil (CellCept)University of Texas Southwestern Medical CenterAspreva PharmaceuticalsNot recruiting18 Years55 YearsBoth43Phase 2United States
1180NCT00331747May 200619 February 2015Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer AcetateThree Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer AcetateMultiple SclerosisDrug: Glatiramer acetateSheba Medical CenterRecruiting18 YearsN/ABoth20N/AIsrael
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1181NCT00340834May 200616 December 2017Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseA 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseMultiple SclerosisDrug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: Interferon ß-1a 30 µgNovartisNot recruiting18 Years55 YearsAll1292Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Egypt;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico
1182NCT02517788May 200617 August 2015Phase I BP Interferon (IFN) Beta-004Comparative Pharmacokinetic Profile of Interferon Beta-1a (Bioferon®) Administered as Single i.v. Doses in HSA-free Formulation and HSA+ Solution and as Multiple s.c. Doses in Healthy SubjectsMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1a HSA-free biosimilar;Drug: Interferon beta-1a HSA+ biosimilar;Drug: Interferon beta-1a originalCentre Hospitalier Universitaire VaudoisBioPartners GmbHNot recruiting18 Years45 YearsBoth24Phase 1
1183EUCTR2006-002562-19-IT21/04/200619 March 2012Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHTImmunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHTVERIFICARE Patients with multiple sclerosis, age between 18 and 50
MedDRA version: 6.1 Level: PT Classification code 10028245
Trade Name: L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE
Product Name: Thymoglobuline
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Antithymocyte
Current Sponsor code: LIGHT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Endoxan - ciclofosfamide
Product Name: Endoxan
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Cyclophosfamide
Current Sponsor code: LIGHT
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di GenovaAuthorisedFemale: yes
Male: yes
12Italy
1184EUCTR2005-005265-11-GB03/04/200619 March 2012A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjectsA double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjectsRelief of central neuropathic pain in subjects with multiple sclerosis (MS)Product Name: Sativex
Product Code: GW-1000-02
Pharmaceutical Form: Oromucosal spray
CAS Number: 1972-08-3
Other descriptive name: delta-9-tetrahydrocannabinol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 27-
CAS Number: 13956-29-1
Other descriptive name: Cannabidiol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Oromucosal use
GW Pharma LtdAuthorisedFemale: yes
Male: yes
312Czech Republic;United Kingdom;France
1185EUCTR2005-001540-23-SE03/03/200619 March 2012A Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double doseA Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double doseEarly Secondary Progressive Multiple SclerosisTrade Name: Betaferon
Product Name: Betaferon
Pharmaceutical Form: Powder for solution for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2x250-
Trade Name: Betaferon
Product Name: Betaferon
Pharmaceutical Form: Powder and solvent for solution for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Schering Nordiska ABNot RecruitingFemale: yes
Male: yes
160Denmark;Sweden
No.TrialIDDate_
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1186NCT00291148March 200619 February 2015Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic PainA Comparative Single Center, Randomized Neuropathic Pain Assessment Study Involving Patients With Clinically Definite Multiple Sclerosis (MS) Receiving Treatment With Either Pregabalin or ParoxetineNeuropathic Pain;Multiple SclerosisDrug: paroxetine;Drug: pregabalin;Drug: ParoxetineUniversity of ManitobaNot recruiting18 Years65 YearsBoth75Phase 3Canada
1187NCT00297232March 200619 October 2017Natalizumab (Tysabri) Re-Initiation of DosingAn Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety EvaluationRelapsing-Remitting Multiple SclerosisDrug: NatalizumabBiogenNot recruiting18 YearsN/AAll1094Phase 3Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria
1188NCT00306592March 200616 December 2017Natalizumab Re-Initiation of DosingAn Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety EvaluationMultiple Sclerosis, Relapsing-RemittingBiological: BG00002 (natalizumab)BiogenElan PharmaceuticalsNot recruiting18 YearsN/AAll404Phase 3United States;Canada
1189NCT00317941March 200619 October 2017Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or RebifThe AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).Relapsing-remitting Multiple SclerosisDrug: Betaferon/Betaseron;Drug: RebifBayerNot recruiting18 Years55 YearsAll220Phase 4France
1190EUCTR2004-004403-37-DE27/02/200619 March 2012Eine monozentrische, randomisierte, kontrollierte Studie zur Untersuchung von Interferon-beta zur Behandlung der Multiplen-Sklerose (MS)-assoziierten und primären Uveitis intermedia im Vergleich zur Standardtherapie A monocentric, randomised, controlled trial for the investigation of Interferon-beta in the treatment of multiple-slerosis (MS)-associated and primary uveitis intermedia compared to the standardized treatment - TEAM-StudieEine monozentrische, randomisierte, kontrollierte Studie zur Untersuchung von Interferon-beta zur Behandlung der Multiplen-Sklerose (MS)-assoziierten und primären Uveitis intermedia im Vergleich zur Standardtherapie A monocentric, randomised, controlled trial for the investigation of Interferon-beta in the treatment of multiple-slerosis (MS)-associated and primary uveitis intermedia compared to the standardized treatment - TEAM-StudieUveitis intermedia with inflammatory macula edema with or without associated Multiple SclerosisProduct Name: Rebif
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Product Name: Rebif
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Product Name: Metex
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: Methotrexat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Universitätsklinikum HeidelbergAuthorisedFemale: yes
Male: yes
Germany
No.TrialIDDate_
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1191EUCTR2005-004334-41-GB10/02/200617 October 2016An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Laquinimod
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: ABR-215062 sodium salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
Teva Pharmaceutical Industries LtdAuthorisedFemale: yes
Male: yes
105Phase 2Hungary;Czech Republic;Poland;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom
1192NCT00382629February 200619 February 2015BHT-3009 Immunotherapy in Relapsing Remitting Multiple SclerosisBHT-3009 Immunotherapy in Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BHT-3009 0.5 mg;Drug: BHT-3009 1.5 mg;Drug: PlaceboBayhill TherapeuticsNot recruiting18 Years55 YearsBoth252Phase 2
1193NCT00492765February 200619 February 2015Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple SclerosisA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment IM Administered Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: Interferon-beta-1a;Drug: Simvastatin;Drug: PlaceboBiogen IdecNot recruiting18 Years55 YearsBoth380Phase 4Denmark
1194EUCTR2005-005263-29-GB31/01/200618 April 2012Multiple Sclerosis and Extract of Cannabis (MUSEC): A randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis. - MUSEC studyMultiple Sclerosis and Extract of Cannabis (MUSEC): A randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis. - MUSEC studyMultiple SclerosisProduct Name: Cannador
Pharmaceutical Form: Capsule, soft
Current Sponsor code: Standardised Cannabis Extract
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Gesellschaft fuer klinische Forschung e.V. (Society for Clinical Research)WELEDA AGAuthorisedFemale: yes
Male: yes
300Phase 3United Kingdom
1195EUCTR2005-004289-18-FI26/01/200619 March 2012A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline)A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline)Relapse Remitting Multiple Sclerosis
MedDRA version: 8.0 Level: PT Classification code 10063399
Product Name: Minocycline 100 mg Film-coated Tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Minocycline Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Merck ABNot RecruitingFemale: yes
Male: yes
320Finland;Sweden
No.TrialIDDate_
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1196EUCTR2005-003903-35-GB19/01/20063 April 2012: The Role of Keppra in the Treatment of Tremor in Multiple Sclerosis: The Role of Keppra in the Treatment of Tremor in Multiple SclerosisMultiple SclerosisTrade Name: Keppra 250mg
Pharmaceutical Form:
INN or Proposed INN: Levetiracetam
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 250mg bd-1500mg bd
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Keppra 500mg
Product Name: Keppra ®
Pharmaceutical Form:
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Newcastle-upon-Tyne Hospitals NHS TrustAuthorisedFemale: yes
Male: yes
United Kingdom
1197EUCTR2005-003930-16-SE19/01/200619 March 2012A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBINA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBINPatients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a.
MedDRA version: 7.0 Level: PT Classification code 10028425
Product Name: Simvastatin Alternova
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 40-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Biogen Idec A/SNot RecruitingFemale: yes
Male: yes
380Finland;Sweden
1198EUCTR2005-005211-21-FI17/01/200619 March 2012A long term follow up of relapsing remitting multiple sclerosis patients who have been treated with intereron beta -1b (Betaferon) at least 5 yearsA long term follow up of relapsing remitting multiple sclerosis patients who have been treated with intereron beta -1b (Betaferon) at least 5 yearsRemitting relapsing multiple sclerosis (RRMS) is one of the most common diseases of the central nervous system. The cause of MS is not yet known but it is a result of damage to myelin. Symptoms vary widely and include blurred vision, weak limbs, tingling sensations, unsteadiness and fatigue.Trade Name: Betaferon
Product Name: Betaferon
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Beta-1b interferoni
Concentration unit: µg/ml microgram(s)/millilitre
Schering OyNot RecruitingFemale: yes
Male: yes
80Finland
1199NCT00280592January 200619 February 2015Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis PatientsProspective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.Multiple Sclerosis;Urinary Tract Infections;Bladder DysfunctionDrug: Cranberry;Drug: PlaceboRennes University HospitalPierre Fabre Laboratories;Ministry of Health, FranceNot recruiting18 Years70 YearsBoth171Phase 3France
1200NCT00289978January 200619 October 2017Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisA 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: PlaceboNovartisNot recruiting18 Years55 YearsAll1272Phase 3Australia;Belgium;Canada;Czech Republic;Finland;France;Germany;Greece;Israel;Lithuania;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom;Italy
No.TrialIDDate_
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1201NCT00818103January 200619 February 2015Characteristic Study on Chinese Patients With Multiple SclerosisCharacteristic Study on Chinese Patients With Multiple SclerosisMultiple SclerosisDrug: atorvastatin;Drug: ß-interferon;Drug: EPOSun Yat-sen UniversityThird Affiliated Hospital, Sun Yat-Sen UniversityRecruitingN/A65 YearsBoth600N/AChina
1202EUCTR2006-006465-16-DE9 May 2016Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MSPilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MSMultiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Trade Name: Genotropin
Product Name: Genotropin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: human recombinant growth hormone
CAS Number: 12629-01-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-12
University of LeipzigNot RecruitingFemale: yes
Male: yes
Phase 2Germany
1203EUCTR2005-000365-19-SE19/12/200519 March 2012A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
Pharmaceutical Form: Capsule*
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5, 1.25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
1250Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden
1204NCT00241254December 200519 February 2015Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple SclerosisA Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S StudyMultiple Sclerosis, Chronic ProgressiveDrug: Cyclophosphamide (drug);Drug: Methylprednisolone (drug)University Hospital, BordeauxMinistry of Health, FranceNot recruiting18 Years65 YearsBoth138Phase 3France
1205NCT00676156December 200519 February 2015A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple SclerosisA Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple SclerosisMultiple SclerosisDrug: oral lipoic acid (LA);Drug: lipoic acid (LA) with fish oil and LA without fish oil;Drug: R lipoic acidOregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH)Not recruiting18 Years80 YearsBoth40Phase 1United States
No.TrialIDDate_
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1206NCT01142466December 200519 October 2017A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After MitoxantronePhase IV, Multicenter, Open Label, Randomized Study of Rebif® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After MitoxantroneMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1a (Rebif)Merck KGaAGesellschaft für Therapieforschung mbHNot recruiting18 Years60 YearsAll30Phase 4
1207EUCTR2005-003410-15-SE21/11/200519 March 2012A twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MSA twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MSMultiple sclerosis is a devastating inflammation in the central nervous system and it can often give cognitive dysfunction, affecting memory, mental concentration. Lately it has been shown that the cognitive dysfunction has a big impact on life quality. Immunomodulatory medication can only partially limit the bouts but there is no effective cure at the moment. There is little options to treat the effects on higher functions for the moment.Trade Name: Aricept 5 mg filmdragerade tabletter
Product Name: Aricept 5 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Donepezil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Aricept 10 mg filmdragerade tabletter
Product Name: Aricept 10 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Donepezil
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Neurology UnitNot RecruitingFemale: yes
Male: yes
20Sweden
1208NCT00273364November 16, 200515 April 2019Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized StudyHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyMultiple SclerosisProcedure: Hematopoietic Stem Cell Therapy;Drug: Standard treatment with a conventional drugNorthwestern UniversityUppsala University;Sheffield Teaching Hospitals NHS Foundation Trust;University of Sao PauloNot recruiting18 Years55 YearsAll110Phase 2United States
1209EUCTR2005-001008-37-SE01/11/200519 March 2012Analysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibodyAnalysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibodyMultiple sclerosisTrade Name: Rebif®
Product Name: Rebif®
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Current Sponsor code: Not applicable
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22, 44-
Sahlgrenska University HospitalAuthorisedFemale: yes
Male: yes
100Sweden
1210NCT00270816November 200518 January 2018Interferon ß-1b Treatment by Cyclical AdministrationEffect of Cyclical Administration of Interferon ß-1b in Multiple Sclerosis - Comparison With Normal Dose.Multiple SclerosisDrug: Interferon-ß-1b;Drug: Interferon ß-1bS. Andrea HospitalItalian Multiple Sclerosis FoundationNot recruiting18 Years55 YearsAll60Phase 2/Phase 3Italy
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1211NCT00242268October 200519 February 2015A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: SimvastatinAlabama Neurology Associates, PCBiogen IdecRecruiting18 Years55 YearsBoth30Phase 3United States
1212EUCTR2005-001949-42-GB08/09/200524 April 2012A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosisA randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosisMultiple sclerosisProduct Name: Lamotrigine extended release tablets
Product Code: N/A
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Lamotrigine
CAS Number: N/A
Current Sponsor code: N/A
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
University College LondonAuthorisedFemale: yes
Male: yes
United Kingdom
1213NCT00220506September 200519 February 2015Fatigue Treatment Using ProvigilFatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple SclerosisAll Multiple Sclerosis PatientsDrug: ProvigilSheba Medical CenterRecruiting18 Years55 YearsBoth50N/AIsrael
1214NCT00754832September 200519 October 2017American Ginseng Treatment for Multiple Sclerosis Related FatigueA Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related FatigueMultiple SclerosisDrug: American ginseng extract HT-1001;Drug: placeboOregon Health and Science UniversityNational Multiple Sclerosis SocietyNot recruiting18 Years70 YearsAll56Phase 2United States
1215NCT01074619September 200519 February 2015Study on Cognitive Disorders of Multiple SclerosisEffects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Memantine;Drug: PlaceboUniversity Hospital, CaenMinistry of Health, France;H. Lundbeck A/SNot recruiting18 Years60 YearsBoth90Phase 3France
No.TrialIDDate_
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PhaseCountries
1216EUCTR2005-006071-12-IT31/08/200519 March 2012Evaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCEEvaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCEMULTIPLE SCLEROSIS
MedDRA version: 6.1 Level: PT Classification code 10028245
Trade Name: EPARMEFOLIN 30 CPR 0,1/0,5MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CALCIO FOLINATO DC.IT
CAS Number: 1492-18-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
INN or Proposed INN: CIANOCOBALAMINA FU DC.IT
CAS Number: 68-19-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Trade Name: LEVOFOLENE 4 MG 30 CPR
Pharmaceutical Form: Tablet
INN or Proposed INN: Calcium levofolinate
CAS Number: 80433-71-2
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
AZIENDA OSPEDALIERA SAN CAMILLO FORLANININot RecruitingFemale: yes
Male: yes
276Italy
1217EUCTR2005-001340-22-GB12/08/200524 April 2012BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSISBHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSISMultiple sclerosis results from an auto-immune reaction characterized by inflammation within the nervous system. Myelin basic protein is a target of the autoimmune response and is generally regarded as the predominant autoantigen. BHT-3009 is a 3.5 kb bacterial plasmid expression vector containing the coding sequences for full length human myelin basic protein (hMBP).Product Name: BHT-3009
Product Code: BHT-3009
Pharmaceutical Form: Solution for injection
Current Sponsor code: BHT-3009
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Bayhill TherapeuticsAuthorisedFemale: yes
Male: yes
252Finland;Czech Republic;United Kingdom
1218EUCTR2005-001776-13-DE05/08/200519 March 2012Efficacy of Levetiracetam in the treatment of spasticity in MS: a ranomized double blind cross over studyEfficacy of Levetiracetam in the treatment of spasticity in MS: a ranomized double blind cross over studyMultiple SclerosisProduct Name: Levetiracetam
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Organisation name was not enteredAuthorisedFemale: yes
Male: yes
24Germany
1219NCT00239993August 200516 December 2017A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.Multiple SclerosisDrug: glatiramer acetate;Procedure: Warm compress prior to injection of glatiramer acetateTeva Neuroscience, Inc.Not recruiting18 Years55 YearsAll50Phase 4United States
1220NCT00915577August 200519 February 2015Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex SyringeAn Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis SubjectsMultiple SclerosisDrug: Interferon beta-1a;Device: Single-use autoinjectorBiogen IdecNot recruiting18 Years65 YearsBoth74Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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Status
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agemin
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agemax
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gender
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size
PhaseCountries
1221EUCTR2004-004903-39-GB26/07/20051 May 2012A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPTA pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPTEarly, active relapsing remitting Multiple Sclerosis (RRMS)Trade Name: Mitoxantrone
Product Name: Mitoxantrone
Pharmaceutical Form:
Trade Name: Copaxone
Product Name: Glatiramer Acetate
Pharmaceutical Form: Injection*
Trade Name: Rebif 44
Product Name: Interferon Beta 1a
Pharmaceutical Form: Injection*
The Walton Centre for Neurology and NeurosurgeryAuthorisedFemale: yes
Male: yes
60United Kingdom
1222EUCTR2005-001009-25-IT16/07/20057 January 2013Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNAEfficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNAMultiple sclerosis treatment
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TORVAST*10CPR 10MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Atorvastatin
CAS Number: 134523-03-8
Concentration unit: mg milligram(s)
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: TORVAST*10CPR 10MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Atorvastatin
Concentration unit: mg milligram(s)
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
DR DIMENSIONE RICERCANot RecruitingFemale: yes
Male: yes
Italy
1223EUCTR2005-001026-89-DE14/07/20057 January 2013Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study)Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study)Relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) with relapses
MedDRA version: 7.1 Level: LLT Classification code 10028245
Trade Name: Rebif
Product Name: Rebif 8,8 µg, Rebif 22µg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1 a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 8,8 or 22-
Trade Name: Rebif
Product Name: Rebif 44 µg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1 a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Serono GmbHNot RecruitingFemale: yes
Male: yes
100Phase 4Germany
1224NCT00122954July 200516 December 2017Fish Oil for the Treatment of Depression in Patients With Multiple SclerosisFish Oil as an Adjunct Therapy for Depression in Multiple SclerosisMultiple Sclerosis;DepressionDrug: Fish oil concentrate;Drug: PlaceboOregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH)Not recruiting18 Years85 YearsAll39Phase 1/Phase 2United States
1225NCT00202423July 200519 February 2015Use of Cannabinoids in Patients With Multiple SclerosisfMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple SclerosisMultiple SclerosisDrug: SativexS. Andrea HospitalUniversity of Roma La SapienzaRecruiting18 Years60 YearsBoth20Phase 2Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
1226NCT01142518July 200519 February 2015An Observational Study of Multiple Sclerosis (MS) Patients Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment With MitoxantroneA Prospective Analysis of MS Patients After Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation TreatmentRelapsing-Remitting Multiple SclerosisDrug: Interferon beta 1aMerck KGaANot recruitingN/AN/ABoth86N/A
1227NCT00127075June 200519 February 2015POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple SclerosisPOPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple SclerosisMultiple SclerosisDrug: nomegestrol acetate;Drug: estradiol;Drug: placeboHospices Civils de LyonNot recruiting18 Years50 YearsFemale300Phase 3France
1228NCT00202397June 200519 February 2015Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar AtaxiaPhase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar AtaxiaHereditary Ataxia;Multiple Sclerosis;Cerebellar AtaxiaDrug: Riluzole;Other: placeboS. Andrea HospitalNot recruiting18 Years80 YearsBoth40Phase 2Italy
1229NCT00463710June 200519 February 2015Effect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With MSEffect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With Relapsing-Remitting and Secondary-Progressive Multiple SclerosisMultiple SclerosisDrug: Avonex® monotherapy (6.0 MIU administered i.m. each week)State University of New York at BuffaloBiogen IdecNot recruiting18 Years65 YearsBoth150Phase 4United States
1230NCT01450488June 200518 December 2018Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple SclerosisA Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple SclerosisMultiple SclerosisDrug: masitinibAB ScienceNot recruiting18 Years60 YearsAll35Phase 2
No.TrialIDDate_
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size
PhaseCountries
1231EUCTR2004-005148-28-FI26/05/20051 May 2012A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSRelapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0 Level: PT Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
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
Merck Serono International S.A.Not RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
1232EUCTR2005-000171-18-FI12/05/200519 March 2012A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/AA Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/AMultiple Sclerosis (Relapsing-remitting MS and Secondary progressive MS with relapses)Product Name: Temsirolimus Tablets
Product Code: CCI-779
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Temsirolimus
Current Sponsor code: CCI-779
Other descriptive name: WAY-130799
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and DevelopmentNot RecruitingFemale: yes
Male: yes
180Finland
1233NCT00094172May 200516 December 2017Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin in Patients With Clinically Isolated Syndrome and High Risk of Conversion to Multiple Sclerosis (ITN020AI)Multiple SclerosisDrug: Atorvastatin;Drug: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Not recruiting18 Years55 YearsAll82Phase 2United States;Canada
1234NCT00127530May 200519 October 2017Study of Oral Fampridine-SR in Multiple SclerosisDouble-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple SclerosisMultiple SclerosisDrug: Fampridine-SR;Drug: PlaceboAcorda TherapeuticsNot recruiting18 Years70 YearsAll301Phase 3United States;Canada
1235NCT00942591May 200519 February 2015Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1bEfficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis.Multiple SclerosisDrug: Interferon beta 1b;Drug: AtorvastatinUniversity Hospital Inselspital, BerneCRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 BaselNot recruiting18 Years55 YearsBoth77Phase 2Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
1236NCT01142453May 200519 February 2015An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) PatientsTherapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in MS Patients. Case Series for Adjustment of Treatment Strategy and Its MonitoringRelapsing-Remitting Multiple SclerosisDrug: Interferon beta 1aMerck KGaAGesellschaft für Therapieforschung mbHNot recruitingN/AN/ABoth231N/A
1237NCT01199640May 200519 February 2015Study of the Safety and Efficacy of MLN1202 in Patients in Multiple SclerosisA Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in Patients in Multiple SclerosisMultiple SclerosisDrug: MLN1202Millennium Pharmaceuticals, Inc.Not recruiting18 YearsN/ABoth50Phase 2
1238NCT02515695May 200517 August 2015Phase I BP Interferon (IFN) Beta-001Bioavailability, Pharmacokinetic and Pharmacodynamic Profile of Interferon Beta-1a (Bioferon®) Administered i.v. and s.c. as Single Doses to Healthy SubjectsMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1aCentre Hospitalier Universitaire VaudoisBioPartners GmbHNot recruiting18 Years45 YearsBoth12Phase 1
1239EUCTR2004-002567-24-CZ04/04/200519 March 2012A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcableA Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcableThe purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).Product Name: MLN1202
Product Code: MLN1202
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Not yet available
Current Sponsor code: Not yet available
Other descriptive name: Not yet available
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Millennium Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
160Phase 2aHungary;United Kingdom;Czech Republic
1240NCT00109161April 200519 February 2015Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple SclerosisA Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)PDL BioPharma, Inc.Not recruiting18 Years55 YearsBoth270Phase 2United States;Canada
No.TrialIDDate_
enrollement
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PhaseCountries
1241NCT00213135April 200519 October 2017A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: Cladribine 5.25 mg/kg;Drug: Cladribine 3.5 mg/kg;Other: PlaceboEMD SeronoNot recruiting18 Years65 YearsAll1326Phase 3Canada;Switzerland
1242NCT00668343April 200519 February 2015Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to PlaceboRelapsing Remitting Multiple SclerosisDrug: simvastatin;Drug: placeboTehran University of Medical SciencesNot recruiting15 Years60 YearsBoth80Phase 3Iran, Islamic Republic of
1243EUCTR2004-002509-63-CZ11/03/200519 March 2012A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/AA double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/ASpasticity due to Multiple Sclerosis (MS)Product Name: Sativex
Product Code: GW-1000-02
Pharmaceutical Form: Oromucosal spray
Other descriptive name: delta-9-tetrahydrocannabinol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 27-
Other descriptive name: cannabidiol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Oromucosal use
GW Pharma LtdNot RecruitingFemale: yes
Male: yes
284United Kingdom;Czech Republic
1244EUCTR2004-003799-13-LT08/03/20051 May 2012A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSRelapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0 Level: PT Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon-beta-1a
CAS Number: 9008-11-1
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Serono International SANot RecruitingFemale: yes
Male: yes
230Phase 3bUnited Kingdom;Spain;Ireland;Sweden;Lithuania
1245NCT00146159March 200519 February 2015Study Evaluating Mitoxantrone in Multiple SclerosisA Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisDrug: MitoxantroneWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years55 YearsBoth336Phase 3Germany
No.TrialIDDate_
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PhaseCountries
1246NCT01599234March 200519 October 2017A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple SclerosisA Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis.Multiple SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll337Phase 3United Kingdom
1247EUCTR2004-003761-33-ES17/02/200519 March 2012Unicenter double-blind, cross-over, randomised, placebo controlled clinical trial to evaluate efficacy of vardenafil in subjects with E.D. and multiple sclerosis (M.S.) - EMDEUnicenter double-blind, cross-over, randomised, placebo controlled clinical trial to evaluate efficacy of vardenafil in subjects with E.D. and multiple sclerosis (M.S.) - EMDEErectile DysfunctionTrade Name: Levitra
Product Name: Vardenafil (hidrocloride)
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: VARDENAFILO HIDROCLORURO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Buccal tablet
Route of administration of the placebo: Oral use
Trade Name: Levitra
Product Name: Vardenafil (hidrocloride)
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: VARDENAFILO HIDROCLORURO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Buccal tablet
Route of administration of the placebo: Oral use
Trade Name: Levitra
Product Name: Vardenafil (hidrocloride)
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: VARDENAFILO HIDROCLORURO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Buccal tablet
Route of administration of the placebo: Oral use
Unidad de NeuroinmunologíaAuthorisedFemale:
Male: yes
28Spain
1248EUCTR2004-004130-14-AT17/02/200522 April 2013A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week).Product Name: Natalizumab
Product Code: Not Applicable
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: natalizumab
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
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Biogen Idec GmbHNot RecruitingFemale: yes
Male: yes
1050Austria
1249EUCTR2004-003943-28-HU14/02/20058 May 2012A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsA multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsRelapsing Remitting Multiple Sclerosis
MedDRA version: 5.1 Level: PT Classification code 10028245
Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
Pharmaceutical Form: Tablet
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: ABR-215062 sodium salt
Other descriptive name: PNU-215062 sodium salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Teva Pharmaceutical Industries LtdNot RecruitingFemale: yes
Male: yes
265Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy
1250EUCTR2004-003799-13-SE03/02/20051 May 2012A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSRelapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0 Level: PT Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon-beta-1a
CAS Number: 9008-11-1
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Serono International SANot RecruitingFemale: yes
Male: yes
230Phase 3bUnited Kingdom;Spain;Ireland;Lithuania;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1251NCT00190268February 200519 February 2015Efficacy of 3,4-DAP in Fatigue Associated With Multiple SclerosisMulticentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple SclerosisMultiple SclerosisDrug: 3,4-diaminopyridineAssistance Publique - Hôpitaux de ParisNot recruiting18 Years60 YearsBoth126Phase 3France
1252EUCTR2004-004519-43-CZ12/01/20051 May 2012Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple SclerosisPhase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple SclerosisRelapsing Multiple SclerosisProduct Code: RO0506997
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO0506997
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: RO0506997
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO0506997
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: RO0506997
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO0506997
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
200Phase 2Germany;United Kingdom;Czech Republic;Spain
1253NCT00110396January 200519 October 2017Rebif New Formulation (RNF) in Relapsing Forms of Multiple SclerosisA Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: Interferon-beta-1a FBS-free/HSA-freeEMD SeronoPfizerNot recruiting18 Years60 YearsAll260Phase 3United States
1254NCT00139789January 200519 February 2015A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple SclerosisA Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple SclerosisMultiple SclerosisDrug: KemstroUCB PharmaNot recruiting18 Years65 YearsBoth60Phase 3United States
1255NCT00203047January 200519 October 2017Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer AcetateA Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA)Relapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Placebo;Drug: PrednisoneTeva Pharmaceutical IndustriesNot recruiting18 Years55 YearsAll414Phase 4Canada;United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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size
PhaseCountries
1256NCT00206635January 200519 February 2015Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple SclerosisA Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting33 YearsN/ABoth432N/AUnited States;Canada;United Kingdom
1257NCT00211887January 200519 October 2017Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRxA Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)Relapsing Remitting Multiple SclerosisDrug: Interferon beta 1-a;Drug: glatiramer acetate;Other: placeboFred LublinNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years60 YearsAll1008Phase 3United States;Canada
1258NCT01142492January 200519 February 2015A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif®)Postmarketing Surveillance Study on the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis With Interferon Beta 1a (Rebif®)Relapsing-Remitting Multiple SclerosisDrug: Interferon beta-1aMerck KGaANot recruitingN/AN/ABoth403N/A
1259NCT01201343January 200519 October 2017Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis PatientsEvaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis PatientsMultiple Sclerosis, Relapsing, RemittingDrug: Interferon beta-1aMerck KGaAMerck Serono S.A.S, FranceNot recruiting18 YearsN/AAll79Phase 4
1260NCT00097188December 200419 February 2015A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: rituximabGenentech, Inc.Not recruiting18 Years55 YearsBoth104Phase 2United States
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
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gender
Target_
size
PhaseCountries
1261NCT00200655December 20049 May 2016Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple SclerosisSafety and Efficacy of Pravastatin in Relapsing-remitting MS: a Double Blind Placebo Controlled StudyRelapsing-remitting Multiple SclerosisDrug: Pravastatin;Drug: PlaceboNantes University HospitalNot recruiting18 Years45 YearsBoth40Phase 3France
1262NCT00203099December 200419 February 2015Safety and Efficacy Study of Copaxone Administered in Combination With N-AcetylcysteineA Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS)Relapse Remitting Multiple SclerosisDrug: Glatiramer Acetate, N-AcetylcysteineTeva Pharmaceutical IndustriesNot recruiting18 Years50 YearsBoth18Phase 2Canada
1263NCT00360906December 200419 February 2015Omega-3 Fatty Acid Treatment in Multiple SclerosisOmega-3 Fatty Acid Treatment in Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: Triomar™ (omega-3 fatty acids)Haukeland University HospitalThe Multiple Sclerosis National Competence Centre;The Norwegian Multiple sclerosis Society;Pronova BioPharma;Serono Nordic;Amersham HealthNot recruiting18 Years55 YearsBoth100Phase 2/Phase 3Norway
1264NCT00869726December 200419 February 2015A Study for Patients With Secondary Progressive Multiple SclerosisA Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisDrug: dirucotide;Drug: PlaceboEli Lilly and CompanyBioMS Technology Corp.Not recruiting18 Years65 YearsBoth596Phase 2/Phase 3Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom
1265EUCTR2004-000555-42-NO22/11/200414 August 2012A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSOA randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSOMultiple sclerosisProduct 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: 7-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sanofi-aventis US, IncNot RecruitingFemale: yes
Male: yes
1080Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
1266EUCTR2004-001601-10-IT19/11/200419 March 2012MULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASEMULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASEMULTIPLE SCLEROSIS TREATMENT
MedDRA version: 6.1 Level: SOC Classification code 10029205
Trade Name: NOVANTRONE*INF 2MG/ML 5ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Mitoxantrone
CAS Number: 70476-82-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: REBIF*SC 12SIR 12000000UI44MCG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
OSPEDALE S. RAFFAELEAuthorisedFemale: yes
Male: yes
266France;Italy
1267EUCTR2004-000145-38-CZ16/11/200419 March 2012A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis.A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis.Relapse-remitting Multiple Sclerosis (RRMS)
Classification code 10048393
Product Name: Human monoclonal antibody (CNTO 1275) to interleukin-12p40
Product Code: CNTO 1275
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: CNTO 1275
Other descriptive name: Anti-IL-12; Human anti-IL-12 Mab; Human anti-IL-12 IgG1 Mab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use
Centocor B.V.AuthorisedFemale: yes
Male: yes
250Phase 2Hungary;United Kingdom;Czech Republic
1268NCT00101959November 200419 February 2015Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) SubjectsAn Implementation Study of Treatment Optimization Recommendations Comparing Subjects Continuing Treatment With IFN-ß-1a 30 Mcg qw IM (Avonex®) or Glatiramer Acetate 20 mg qd SC (Copaxone®) to Those Randomized to IFN-ß-1a 44 Mcg Tiw SC (Rebif®), in a Multicenter Study of Subjects With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying TherapyRelapsing-Remitting Multiple SclerosisDrug: RebifEMD SeronoNot recruiting18 Years60 YearsBoth0Phase 4United States
1269NCT00151294November 200419 February 2015The Efficacy and Safety of Escitalopram for Depression in Multiple SclerosisA Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple SclerosisDepression;Multiple SclerosisDrug: escitalopram oxalate antidepressantWeill Medical College of Cornell UniversityForest LaboratoriesNot recruiting18 YearsN/ABoth20Phase 4United States
1270EUCTR2004-000759-40-IT22/10/200419 March 2012A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit.
MedDRA version: 6.1 Level: PT Classification code 10028245
Product Name: glatiramer acetate
Product Code: TV-5010
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
Current Sponsor code: TV - 5010
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
TEVANot RecruitingFemale: yes
Male: yes
25Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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PhaseCountries
1271NCT00137176October 200419 February 2015EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple SclerosisEARLY IFNb-1a (Rebif) and Atorvastatin (Lipitor) Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple SclerosisMultiple SclerosisDrug: RebifUniversity of North Carolina, Chapel HillNot recruiting18 Years60 YearsBoth30N/AUnited States
1272NCT00168701October 200419 February 2015Efficacy and Safety of BG00012 in MSDouble-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: BG00012Biogen IdecNot recruiting18 Years55 YearsBoth260Phase 2Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Sweden;Switzerland;Turkey;United Kingdom
1273NCT00240032October 200419 February 2015A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.Multiple SclerosisDrug: glatiramer acetate injection with oral cetirizine hydrochloride;Drug: glatiramer acetate with placeboTeva Pharmaceutical IndustriesNot recruiting18 YearsN/ABoth80Phase 4United States
1274EUCTR2005-000393-47-IT22/09/200419 March 2012Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study.Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study.Treatment of spasticity in patients with Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Trade Name: Cannabis Based Medicine Extract (Sativex)
Pharmaceutical Form: Oromucosal spray
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.7-
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMANot RecruitingFemale: yes
Male: yes
Italy
1275EUCTR2004-000663-99-SE10/09/200419 March 2012Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.Product Name: second-generation fumaric acid
Product Code: BG00012
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dimethyl fumarate
CAS Number: 62008-21
Current Sponsor code: dimethyl fumarate
Other descriptive name: dimethyl fumarate
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Biogen Idec Inc.Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
260Hungary;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
1276EUCTR2004-000073-64-FI03/09/200419 March 2012A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - -A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - -Aaltomainen MS-tautiProduct Code: L-000124467
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Merck & Co., Inc./Suomen MSD OyNot RecruitingFemale: yes
Male: yes
120Finland
1277NCT00097331September 200420 April 2015Three Months Treatment With SB683699 In Patients With Relapsing Multiple SclerosisA Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Three Months Administration of SB-683699 (150 - 1200mg Twice Daily) in Subjects With Relapsing Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: SB683699GlaxoSmithKlineNot recruiting18 Years65 YearsBoth261Phase 2Belgium;Germany;Poland;Russian Federation;Spain;United States;Canada;France;Italy;Romania
1278NCT00146068September 200419 February 2015EARLY IFNB-1a and Simvastatin Combination Therapy in Clinically Isolated Syndrome Suggestive of Multiple SclerosisPhase IV Double-Blind Randomized Study to Evaluate Safety and Efficacy of Interferon Beta-1a (Avonex) Plus Simvastatin (Zocor) Combination Therapy in Clinically Isolated Syndrome Suggestive of Multiple Sclerosis Over a One Year PeriodMultiple SclerosisDrug: Avonex/ZocorUniversity of North CarolinaNot recruiting18 Years60 YearsBoth30Phase 4United States
1279NCT00315367September 200419 February 2015A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory DifficultiesA Double-Blind, Crossover Trial of Aricept® in Memory-Impaired Patients With Multiple Sclerosis: A Phase IV Demonstration of Functional MRI (fMRI) as a Surrogate Marker of Brain Activity Associated With Improvement in Memory FunctionRelapsing-Remitting Multiple SclerosisDrug: Donepezil HCI (drug)NeurognosticsNot recruiting18 Years65 YearsBoth26Phase 4United States
1280EUCTR2004-000762-13-IT31/08/20043 September 2012A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit.
MedDRA version: 15.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Glatiramer acetate
Product Code: TV-5010
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
Current Sponsor code: TV-5010
Concentration unit: mg milligram(s)
Concentration number: 30-
TEVA ITALIA srlAuthorisedFemale: yes
Male: yes
7Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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PhaseCountries
1281NCT00220922August 200419 February 2015A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®Multiple SclerosisProcedure: Alcohol Wipes vs. No Alcohol WipesTeva Neuroscience, Inc.Not recruiting18 YearsN/ABoth50Phase 4United States
1282NCT00239655August 20048 August 2016A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)(0812-003)(COMPLETED)A Randomized, Double-Blind Placebo Controlled, Parallel Groups Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by MRIRelapsing-Remitting Multiple SclerosisDrug: MK0812Merck Sharp & Dohme Corp.Not recruiting18 Years55 YearsBoth120Phase 2Canada;Finland;Germany;United Kingdom;United States
1283EUCTR2004-000047-18-SE27/07/200419 March 2012An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803.An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803.Male and female subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803Product Name: natalizumab
Product Code: AN100226
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: natalizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Biogen Idec Ltd.Not RecruitingFemale: yes
Male: yes
1900Sweden
1284EUCTR2004-000337-12-HU23/07/200419 March 2012A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone StudyA multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone StudyMS with 2 or more relapses within the last 2 years
MedDRA version: 7.0 Level: PT Classification code 10028245
Trade Name: Rebif
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
CAS Number: 9008-11-1
Current Sponsor code: IFN-beta
Other descriptive name: Recombinant human interferon beta
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
CAS Number: 9008-11-1
Current Sponsor code: IFN-beta
Other descriptive name: Recombinant human interferon beta
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Serono International SAAuthorisedFemale: yes
Male: yes
400Phase 4Hungary
1285EUCTR2004-000462-13-HU12/07/200419 March 2012A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).Relapsing-remitting multiple sclerosis (R-R MS)
MedDRA version: 5.1 Level: PT Classification code 10028245
Product Name: Glatiramer acetate 150mg enteric-coated (gastro-resistant) tablets
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Glatiramer Acetate
CAS Number: 147245-92-9
Current Sponsor code: GA
Other descriptive name: COP-1/Copolymer-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
TEVA Pharmaceutical Industries Ltd.Not RecruitingFemale: yes
Male: yes
25Hungary;Italy
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PhaseCountries
1286NCT00103974July 200419 February 2015Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple SclerosisA Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple SclerosisMultiple SclerosisBiological: BHT-3009-01Bayhill TherapeuticsNot recruiting18 Years65 YearsBoth30Phase 1United States;Canada
1287NCT00202995July 200419 February 2015Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMSA Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Betaseron;Drug: RebifTeva Pharmaceutical IndustriesNot recruiting18 Years50 YearsBoth91Phase 4United States;Canada
1288NCT00207727July 200419 October 2017A Safety and Efficacy Study of CNTO1275 in Patients With Multiple SclerosisA Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: CNTO 1275Centocor, Inc.Centocor BVNot recruiting18 Years65 YearsAll249Phase 2Australia;Canada;Czech Republic;Hungary;Poland;United Kingdom;United States
1289NCT00223301July 200419 February 2015Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple SclerosisA One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple SclerosisMultiple SclerosisDrug: Mycophenolate Mofetil (cellcept)University of Texas Southwestern Medical CenterRoche Pharma AG;Biogen IdecNot recruiting21 Years45 YearsBoth24Phase 2/Phase 3United States
1290EUCTR2004-000374-31-IT09/06/200419 March 2012A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple SclerosisA Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple SclerosisRelapsing Multiple SclerosisTrade Name: ALTRI FARMACI DEL SISTEMA NERVOSO
Product Name: NA
Product Code: aSB-683699
Pharmaceutical Form: Tablet
Current Sponsor code: SB683699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
GLAXO SMITHKLINENot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
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1291NCT00087529June 200419 October 2017A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple SclerosisA Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple SclerosisMultiple SclerosisDrug: placebo;Drug: rituximabGenentech, Inc.Not recruiting18 Years65 YearsAll439Phase 2/Phase 3Canada;United States
1292NCT00203112June 200419 February 2015Safety and Efficacy Study of Copaxone Administered in Combination With MinocyclineA Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA).Relapse Remitting Multiple SclerosisDrug: glatiramer acetate with minocycline;Drug: Glatiramer acetate with placeboTeva Pharmaceutical IndustriesNot recruiting18 Years50 YearsBoth44Phase 2Canada
1293NCT01142557June 200419 February 2015An Observational Study to Document the Effectiveness and Compatibility of Rebif 44 or 22 µg in the Therapy of the Chronic Multiple SclerosisTherapy of the Chronic Multiple Sclerosis With Interferon-beta 1a (Rebif®)Multiple SclerosisDrug: Interferon beta-1a (Rebif)Merck KGaAGesellschaft für Therapieforschung mbHNot recruitingN/AN/ABoth522N/AGermany
1294NCT00367484May 200419 October 2017Study To Evaluate The Immunogenicity And Safety Of r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In Multiple SclerosisMulticentre, Single Arm, Open, Phase IV Study To Evaluate Immunogenicity And Safety Of Subcutaneous r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In The Treatment Of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisBiological: Rebif® (clone 484-39)Merck KGaANot recruiting18 Years60 YearsAll460Phase 4
1295NCT00493077May 200419 February 2015Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta TherapyA Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta TherapyMultiple SclerosisDrug: low immunogenic interferon-beta-1aBiogen IdecNot recruiting18 Years55 YearsBoth3Phase 4Sweden
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1296NCT00682929April 14, 200411 June 2018Cannabis for Spasticity in Multiple SclerosisCannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled StudyMultiple SclerosisDrug: Inhaled Cannabis;Drug: Oral THC;Drug: Oral Placebo;Drug: Inhaled placeboUniversity of California, DavisNational Multiple Sclerosis SocietyNot recruiting21 YearsN/AAll41Phase 1/Phase 2United States
1297NCT00086671April 200419 February 2015Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS)A 24-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Finding, Safety, Tolerability, and Efficacy Study of the Human Anti-IL-12 Antibody ABT-874 in Subjects With Multiple Sclerosis With a 24-Week Double-Blind, Active Extension PhaseMultiple SclerosisDrug: ABT-874/Human monoclonal antibody against IL-12;Drug: PlaceboAbbVie (prior sponsor, Abbott)Not recruiting18 Years60 YearsBoth215Phase 2United States;Canada;Germany;Netherlands;United Kingdom
1298NCT00217295April 200419 February 2015A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple SclerosisA Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.Multiple SclerosisDrug: Avonex and TopamaxMultiple Sclerosis InstituteRecruiting18 Years55 YearsBoth30Phase 2United States
1299NCT00300716April 200422 October 2019Trial of Memantine for Cognitive Impairment in Multiple SclerosisDouble Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple SclerosisMultiple Sclerosis;Cognition DisordersDrug: MemantineOregon Health and Science UniversityForest Laboratories;University of Southern California;University of Texas Southwestern Medical Center;MS-Hub SeattleNot recruiting18 Years65 YearsAll82Phase 2/Phase 3United States
1300NCT01233245April 200419 February 2015BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus ProgramBetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus ProgramRelapsing Remitting MS (RRMS);Secondary Progressive MS (SPMS)Drug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 YearsN/ABoth1077N/ACzech Republic;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Lebanon;Netherlands;Portugal;Saudi Arabia;Spain;Taiwan;Turkey
No.TrialIDDate_
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1301NCT00078338March 200419 February 2015Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple SclerosisPhase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: Human interferon beta-1a and glatiramer acetateEMD SeronoPfizerNot recruiting18 Years60 YearsBoth764Phase 4United States;Argentina;Austria;Brazil;France;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;United Kingdom
1302NCT00168714February 200419 February 2015Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)Avonex Pregnancy Exposure RegistryPrenatal Exposure Delayed Effects;Multiple Sclerosis;PregnancyDrug: BG9418 (interferon beta-1a)Biogen IdecNot recruitingN/AN/AFemale329N/AUnited States
1303NCT00501748January 200419 February 2015Safety and Tolerability of Rituximab in Neuromyelitis OpticaOpen Label Study of Safety and Tolerability of Rituximab in Neuromyelitis Optica, Recurrent Transverse Myelitis and Recurrent Bilateral Simultaneous Optic NeuritisNeuromyelitis OpticaDrug: RituximabUniversity of California, San FranciscoGenentech, Inc.Not recruiting12 Years86 YearsBoth20Phase 1United States
1304NCT00666224January 200419 October 2017Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated SyndromeA Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS)Multiple SclerosisDrug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL)Teva Pharmaceutical IndustriesNot recruiting18 Years45 YearsAll481Phase 3Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States
1305NCT00246324December 200311 June 2018Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple SclerosisAn Open Label Trial of Safety and Efficacy of Combination Therapy With Interferon-B-1a and Oral Doxycycline in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Interferon beta 1a, oral doxycyclineLouisiana State University Health Sciences Center ShreveportBiogenNot recruiting18 Years55 YearsAll16Phase 4United States
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1306NCT00276172December 200319 February 2015Open-Label Natalizumab Safety Extension StudyAn Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803Multiple SclerosisDrug: NatalizumabBiogen IdecNot recruiting18 YearsN/ABoth1615Phase 3United States
1307NCT00099502November 200319 February 2015BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) PatientsInternational, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.Multiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046);Drug: CopaxoneBayerNot recruiting18 Years55 YearsBoth2244Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine
1308NCT00228397November 200319 February 2015Study Evaluating CCI-779 in Relapsing Multiple SclerosisA Multicenter, Randomized, Double-blind, Long-term Extension Study to Determine the Safety, Tolerability, and Preliminary Efficacy of CCI-779 in Subjects With Relapsing Multiple Sclerosis.Multiple Sclerosis, Relapsing-RemittingDrug: CCI-779Wyeth is now a wholly owned subsidiary of PfizerNot recruitingN/AN/ABoth221Phase 2
1309NCT00654927November 200319 October 2017Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple SclerosisPhase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple SclerosisMultiple SclerosisDrug: Fampridine-SR b.i.d. (Twice Daily)Acorda TherapeuticsNot recruiting18 Years70 YearsAll177Phase 3United States;Canada
1310NCT00071838October 30, 200316 December 2017Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple SclerosisZenapax (Daclizumab) Admin to Pts With Multiple Sclerosis (ZAP MS): Effect of Intravenously Admin Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (Daclizumab) on Inflammatory Activity in the Central Nervous SystemMultiple Sclerosis, Relapsing-RemittingDrug: DaclizumabNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years65 YearsAll16Phase 2United States
No.TrialIDDate_
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1311NCT00242177October 200329 July 2019Pilot Test of ACTOS in Multiple Sclerosis: Safety and TolerabilityPilot Test of ACTOS in Multiple Sclerosis: Safety and TolerabilityMultiple Sclerosis, Relapsing-RemittingDrug: ACTOS (Pioglitazone)University of Illinois at ChicagoTakeda Pharmaceuticals North America, Inc.Not recruiting18 Years65 YearsAll30Phase 1United States
1312NCT00296205October 200319 February 2015Phase II High-Dose Cyclophosphamide for Multiple SclerosisPhase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Multiple SclerosisMultiple SclerosisDrug: CyclophosphamideStony Brook UniversityNot recruiting18 Years75 YearsBoth25Phase 2United States
1313NCT00493116October 200319 February 2015Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon BetaA Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced BioavailabilityRelapsing-Remitting Multiple SclerosisDrug: Interferon-beta-1a;Drug: methylprednisoloneBiogen IdecNot recruiting18 Years55 YearsBoth20Phase 4Australia;New Zealand
1314NCT00616187October 200311 June 2018Atorvastatin in Relapsing-Remitting Multiple SclerosisOral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: interferon beta treatment to add-on atorvastatin treatment;Drug: untreated to atorvastatin treatmentCharite University, Berlin, GermanyGerman Research Foundation;German Federal Ministry of Education and Research;PfizerNot recruiting18 Years55 YearsAll41Phase 2
1315NCT00418145September 200316 December 2017Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis AttacksOral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)Multiple SclerosisDrug: megadose oral methylprednisolone;Drug: IV methylprednisoloneFred LublinNational Multiple Sclerosis Society;PfizerNot recruiting18 Years50 YearsAll16Phase 3United States
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1316NCT00202982August 200319 February 2015A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved DoseA Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis PatientsRelapse-Remitting Multiple SclerosisDrug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mgTeva Pharmaceutical IndustriesNot recruiting18 Years50 YearsBoth90Phase 2United States
1317NCT00276341August 200318 December 2018Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple SclerosisEfficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.Multiple Sclerosis, Relapsing-RemittingDrug: EGb 761® (Tanakan®)IpsenNot recruiting18 YearsN/AAll240Phase 3France
1318NCT00913250August 200319 February 2015A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy VolunteersA Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of AVONEX® (Interferon Beta-1a) Solutions for Injection Produced by a Serum-Containing Manufacturing Process and by a Serum-Free Manufacturing ProcessMultiple SclerosisDrug: Serum containing Avonex;Drug: Serum Free AvonexBiogen IdecNot recruiting18 Years45 YearsBoth96Phase 1
1319NCT00079495July 200319 February 2015Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: NBI-5788Neurocrine BiosciencesImmune Tolerance Network (ITN)Not recruiting18 Years55 YearsBoth150Phase 2
1320NCT00097760June 200319 February 2015Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple SclerosisSafety Study of Natalizumab in Combination With Glatiramer Acetate (GA)Multiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogen IdecElan PharmaceuticalsNot recruiting18 Years55 YearsBoth110Phase 2
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1321NCT00112034June 200319 February 2015AVONEX® Combination Trial - ACTA Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monotherapy.Multiple Sclerosis, Relapsing-RemittingDrug: Methotrexate;Drug: IV methylprednisoloneBiogen IdecNot recruiting18 Years55 YearsBoth350Phase 4United States
1322NCT00142402June 200319 February 2015Modafinil in Multiple SclerosisModafinil for Improving New Learning and Memory in Multiple SclerosisMultiple SclerosisDrug: ModafinilKessler FoundationNational Multiple Sclerosis SocietyNot recruiting18 Years60 YearsBoth20N/AUnited States
1323NCT00203073June 200319 February 2015A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantroneTeva Pharmaceutical IndustriesNot recruiting18 Years55 YearsBoth40Phase 2United States;Canada
1324NCT00220493June 200319 February 2015Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) PatientsClinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis PatientsRelapsing Remitting Multiple Sclerosis;Multiple Sclerosis, Chronic ProgressiveDrug: RitalinSheba Medical CenterRecruiting25 Years65 YearsBoth80Phase 1Israel
1325NCT00235989June 200319 October 2017Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple SclerosisAn Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: Interferon beta 1b (Betaseron, BAY86-5046)BayerNot recruiting18 Years55 YearsAll63Phase 2United States
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1326NCT00267319June 200319 February 2015FOCUS Fatigue Outcome in Copaxone USersFatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Glatiramer acetateSanofiNot recruiting18 YearsN/ABoth111Phase 4Czech Republic
1327NCT00278655June 200319 October 2017Hematopoietic Stem Cell Therapy for Patients With Multiple SclerosisHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Interferon Therapy: A Phase II Multi-Center TrialMultiple SclerosisBiological: Hematopoietic stem cell transplantationNorthwestern UniversityNot recruiting18 Years50 YearsAll21Phase 1/Phase 2United States
1328NCT00095329May 20033 October 2016Treating Multiple Sclerosis With Sirolimus, an Immune System SuppressorA Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple SclerosisMultiple Sclerosis (MS) - Relapsing-remittingBiological: sirolimusNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 Years58 YearsBoth14Phase 1/Phase 2United States
1329NCT00333138May 200316 December 2017Efficacy and Safety of FTY720 in Patients With Relapsing Multiple SclerosisDouble-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension PhaseMultiple SclerosisDrug: FTY720;Drug: PlaceboNovartisNot recruiting18 Years60 YearsAll281Phase 2Canada;Denmark;Finland;France;Germany;Italy;Poland;Portugal;Spain;Switzerland;United Kingdom
1330NCT00206648March 200319 February 2015An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MSA Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With AvonexMultiple Sclerosis, Relapsing-RemittingDrug: Betaferon/BetaseronBayerNot recruiting18 Years60 YearsBoth271Phase 4United States;Canada
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1331NCT00260741March 200319 February 2015Cannabis for Spasticity in Multiple SclerosisCannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled StudyMultiple SclerosisDrug: Smoked CannabisCenter for Medicinal Cannabis ResearchNot recruiting21 YearsN/ABoth60Phase 1/Phase 2United States
1332NCT00492466March 200319 February 2015Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing AntibodiesA Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta AntibodiesRelapsing-Remitting Multiple SclerosisDrug: Interferon-beta-1a;Drug: methylprednisoloneBiogen IdecNot recruiting18 Years55 YearsBoth14Phase 4Finland
1333NCT00053417February 200319 October 2017Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple SclerosisDouble-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)Acorda TherapeuticsNot recruiting18 Years70 YearsAll206Phase 2United States;Canada
1334NCT00298662February 200319 February 2015Combination Therapy of Betaseron-Prograf in Multiple SclerosisA Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying AgentsMultiple SclerosisDrug: Interferon beta-1b and TacrolimusClinique de sclérose en plaques et neuromusculaire de l'OutaouaisNot recruiting18 Years55 YearsBoth30Phase 2Canada
1335NCT00076934January 200316 December 2017Safety of RG2077 in Patients With Multiple SclerosisA Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: RG2077 (CTLA4-IgG4m)National Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Repligen CorporationNot recruiting18 Years55 YearsAll20Phase 1United States
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1336NCT00176592January 200319 February 2015Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRIPhase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose GadoliniumMultiple SclerosisDrug: Betaseron;Drug: CopaxoneStuart D Cook MDNot recruiting18 Years55 YearsBoth93Phase 4United States
1337NCT00210301January 200319 February 2015Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MSCombination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MSRelapsing-Remitting Multiple SclerosisDrug: Provigil (modafinil)Institute for Clinical ResearchRecruiting20 Years65 YearsBoth60N/AUnited States
1338NCT00912860January 200319 February 2015Immunogenicity and Safety Study of Serum-Free AvonexA Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1aBiogen IdecNot recruiting18 Years60 YearsBoth155Phase 2
1339NCT00050232December 20028 August 2016Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis PatientsMultiple SclerosisDrug: AVP-923Avanir PharmaceuticalsNot recruiting18 Years68 YearsBoth96Phase 3United States
1340NCT00050778December 200219 October 2017A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple SclerosisA Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: Interferon beta-1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mgGenzyme, a Sanofi CompanyBayerNot recruiting18 Years50 YearsAll334Phase 2United States;Croatia;Poland;Russian Federation;United Kingdom
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1341NCT00220779December 200219 October 2017Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple SclerosisRandomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)Grifols Therapeutics Inc.Not recruiting18 Years55 YearsAll128Phase 2United States;Austria;Canada;Czech Republic;Germany;Greece;Hungary;Israel;Poland;Slovakia;Sweden;United Kingdom
1342NCT00893217November 200219 February 2015BEYOND Pilot StudyDouble-blind, Randomized, Parallel Group, Multicenter Study of the Safety and Tolerability of Betaseron 500 Mcg Subcutaneously Every Other Day and Betaseron 250 Mcg Subcutaneously Every Other Day for at Least 12 Weeks in Patients With RRMSMultiple Sclerosis;Relapsing-RemittingDrug: Betaseron (Interferon beta-1b, BAY86-5046)BayerNot recruiting18 Years55 YearsBoth71Phase 2United States
1343NCT00913666November 200219 February 2015Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy VolunteersA Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control SubjectsMultiple SclerosisDrug: Interferon beta-1a (Avonex)Biogen IdecNot recruiting18 Years65 YearsBoth121Phase 4
1344NCT00185211August 200219 October 2017BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up StudyOpen-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNot recruiting18 Years48 YearsAll468Phase 3Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom
1345NCT00599274August 200219 February 2015Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple SclerosisA Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX® and Rebif® to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS)Multiple SclerosisDrug: Interferon beta-1aBiogen IdecNot recruiting18 Years50 YearsBoth136N/AUnited States;Australia;Austria;Canada
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1346NCT00678795August 200219 October 2017A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple SclerosisA Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis.Detrusor Overactivity;Multiple SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll135Phase 3United Kingdom
1347NCT00587691July 200216 December 2017Dose-Escalation Study of T Cell Vaccine in Multiple SclerosisAn Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary ProgressiveBiological: Tovaxin Autologous T Cell VaccineOpexa Therapeutics, Inc.Not recruiting18 Years65 YearsAll16Phase 1/Phase 2United States
1348NCT00047580June 200221 December 2015Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fasted Conditions in Patients With Moderate to Severe SpasticityMultiple Sclerosis;Muscle Spasticity;Spinal Cord Injury;StrokeDrug: tizanidine hydrochloride capsuleElan PharmaceuticalsNot recruiting18 YearsN/ABoth120Phase 3United States
1349NCT00711646June 200219 October 2017A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis.Spasticity;Multiple SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll189Phase 3United Kingdom
1350NCT00037115May 200211 June 2018Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event.An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results.Demyelinating Disorders;Multiple Sclerosis;Optic Neuritis;Myelitis;NeuritisDrug: interferon beta 1a;Drug: methotrexate;Drug: methylprednisoloneMidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteConsultants in NeurologyNot recruiting18 Years50 YearsAll0Phase 4United States
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1351NCT00151801May 200219 February 2015Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS PatientsSafety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: estroprogestins;Drug: interferon-beta 1aS. Andrea HospitalRecruiting18 Years40 YearsFemale200Phase 2Italy
1352NCT00228228May 200219 February 2015TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple SclerosisT-Cell Vaccination in the Treatment of Probable Multiple SclerosisMultiple SclerosisBiological: T cell vaccinationSheba Medical CenterRecruiting15 Years50 YearsBoth80Phase 3Israel
1353NCT01448252May 200219 February 2015T Cell Vaccination in Patients With Progressive Multiple SclerosisAutologous T Cell Vaccination With Line Specific for 9 Myelin Peptides in Patients With Progressive / Relapsing Multiple SclerosisMultiple SclerosisBiological: multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides);Biological: T cell vaccinationHadassah Medical OrganizationNot recruiting18 Years60 YearsBoth30Phase 1/Phase 2Israel
1354NCT00405353April 200219 February 2015Testosterone Treatment for Multiple SclerosisTestosterone Treatment for Multiple Sclerosis: A Preliminary TrialMultiple SclerosisDrug: Androgel 100mg gelUniversity of California, Los AngelesNational Multiple Sclerosis SocietyNot recruiting18 Years65 YearsMale10Phase 1/Phase 2United States
1355NCT01604265March 200219 October 2017A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple SclerosisA Double Blind, Randomised, Parallel Group, Placebo Controlled Study of Sativex in the Treatment of Central Neuropathic Pain in Multiple Sclerosis.Multiple Sclerosis;Neuropathic PainDrug: Placebo;Drug: SativexGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll66Phase 3United Kingdom
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1356NCT01606176March 200219 October 2017A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological OriginA Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function.Pain;Multiple SclerosisDrug: GW-1000-02;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll70Phase 3United Kingdom
1357NCT00067327February 200219 February 2015Treatment of Multiple Sclerosis Using Over the Counter InosineTreatment of Multiple Sclerosis Using Over the Counter InosineMultiple Sclerosis, Relapsing-RemittingDrug: InosineNational Center for Complementary and Integrative Health (NCCIH)Not recruiting18 Years60 YearsBoth30Phase 2United States
1358NCT01606137February 200219 October 2017A Study of the Long-term Safety of Sativex UseA Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine.Multiple Sclerosis;Spasticity;PainDrug: GW-1000-02GW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll507Phase 3United Kingdom
1359NCT00030966January 200219 February 2015Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogen IdecElan PharmaceuticalsNot recruiting18 Years55 YearsBoth1200Phase 3United States;Austria;Belgium;France;Germany;Israel;Italy
1360NCT00228163January 20027 April 2015Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesExtension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesMultiple SclerosisDrug: teriflunomide (HMR1726)SanofiNot recruiting18 Years65 YearsBoth147Phase 2Canada;France
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1361NCT00027300November 200116 December 2017Safety and Efficacy of Natalizumab in the Treatment of Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogenElan PharmaceuticalsNot recruiting18 Years50 YearsAll900Phase 3United States;Belgium;Canada;Czech Republic;France;Germany;Netherlands;United Kingdom
1362NCT00035529November 200119 February 2015A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple SclerosisA Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: BMS 188667 (Abatacept)Bristol-Myers SquibbNot recruiting18 Years55 YearsBothPhase 2United States
1363NCT00039988November 20013 October 2016Treatment of Multiple Sclerosis With Copaxone and AlbuterolTreatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate) and AlbuterolAutoimmune Diseases;Multiple SclerosisDrug: Glatiramer acetate;Drug: Albuterol;Drug: Albuterol placeboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 Years55 YearsBoth40N/AUnited States
1364NCT00202410November 200119 February 2015Efficacy of Anti-Tubercular Vaccination in Multiple SclerosisPhase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, Randomized, Single Blind Study.Multiple SclerosisBiological: Bacille of Calmette-Guerin;Other: placeboS. Andrea HospitalMultiple Sclerosis Italian Foundation (FISM);Istituto Superiore di SanitàNot recruiting18 YearsN/ABoth80Phase 2/Phase 3Italy
1365NCT00248378September 200119 February 2015Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple SclerosisShort-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple SclerosisMultiple SclerosisDrug: Smoked CannabisCenter for Medicinal Cannabis ResearchNot recruiting18 YearsN/ABoth30Phase 1/Phase 2United States
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1366NCT00304291August 200119 February 2015A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease)A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease)Neuromyelitis Optica;Myelitis, Transverse;Demyelinating Autoimmune Diseases, CNS;Autoimmune Diseases of the Nervous SystemDrug: MitoxantroneState University of New York at BuffaloEMD SeronoNot recruiting18 Years55 YearsBoth5Phase 4United States
1367NCT00037102July 200111 June 2018Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple SclerosisAn Open Label Study of the Safety and Efficacy of Combination Therapy With AVONEX and Bi-Monthly High Dose Intravenous Methotrexate With Leucovorin Rescue in the Treatment of Multiple SclerosisMultiple SclerosisDrug: interferon beta 1a;Drug: methotrexateMidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteConsultants in Neurology;BiogenNot recruiting18 Years60 YearsAll16Phase 4United States
1368NCT01610687July 200119 October 2017A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisA Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple Sclerosis;SpasticityDrug: GW-1000-02GW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll137Phase 3United Kingdom
1369NCT00043264June 200119 February 2015Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple SclerosisAntibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple SclerosisMultiple SclerosisDrug: Rifampin;Drug: AzithromycinNational Center for Research Resources (NCRR)National Multiple Sclerosis SocietyNot recruiting18 Years65 YearsBoth40Phase 2United States
1370NCT01610700May 200119 October 2017An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis PatientsDouble Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple SclerosisDrug: GW-1000-02;Drug: PlaceboGW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll160Phase 3United Kingdom
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1371NCT01610713May 200119 October 2017An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisDouble Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple SclerosisDrug: GW-1000-02GW Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll154Phase 3United Kingdom
1372NCT00017628April 200119 February 2015Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple SclerosisMultiple SclerosisDrug: cyclophosphamide;Drug: filgrastim;Drug: methylprednisolone;Procedure: Autologous Stem Cell TransplantationNorthwestern Memorial HospitalNot recruitingN/A59 YearsBoth20Phase 1United States
1373NCT01487096April 200119 February 2015Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesA Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (placebo for teriflunomide)SanofiNot recruiting18 Years65 YearsBoth179Phase 2Canada;France
1374NCT00011375February 200119 February 2015Rolipram to Treat Multiple SclerosisSafety, Tolerability & Effects of Rolipram on Inflammatory Activity in the Central Nervous System in Multiple Sclerosis. A Phase II, Open Label Crossover Trial Using MRI as an Outcome MeasureMultiple SclerosisDrug: RolipramNational Institute of Neurological Disorders and Stroke (NINDS)Not recruitingN/AN/ABoth52Phase 2United States
1375NCT00179478February 200116 December 2017Long Term Study of Avonex Therapy Following a First Attack of Multiple SclerosisControlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)Multiple Sclerosis;Optic Neuritis;Transverse Myelitis;Acute Brainstem/Cerebellar SyndromeDrug: interferon beta 1a 30 ug IM once weeklyBeth Israel Deaconess Medical CenterBiogenNot recruiting18 YearsN/AAll155Phase 4United States;Canada
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1376NCT01863069January 200119 February 2015Avonex®: Safety, Blood Levels and EffectsA Single-centre Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Inhaled Formulation of AVONEX® (Interferon Beta-1a) in Healthy VolunteersMultiple Sclerosis (MS)Drug: Interferon beta 1a;Drug: (IM) AVONEX®Trio Medicines Ltd.Biogen IdecNot recruiting18 Years45 YearsBoth77Phase 1United Kingdom
1377NCT00292266November 199919 February 2015A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Rebif®;Drug: Avonex®EMD SeronoMerck Serono International SANot recruiting18 Years55 YearsBoth677Phase 3
1378NCT00534261November 199919 February 2015Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?Evaluation of the Correlation Between the MS Functional Composite Index and Two Quality of Life Scales (MS54 and AMS Quality of Life) in Relapsing MS Patients Treated With Interferon Beta-1a (AVONEX®)Relapsing Remitting Multiple SclerosisDrug: Interferon beta-1aBiogen IdecNot recruiting18 Years70 YearsBoth284Phase 4Belgium;Luxembourg;United Kingdom
1379NCT00001934September 199919 February 2015Zenapax to Treat Multiple SclerosisEffect of the Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (IL-2R-Alpha; Zenapax(Registered Trademark)) on Inflammatory Activity in the CNS in MS in a Baseline-to-Treatment, Cross-Over, MRI-Controlled Single Center Phase I/II TrialMultiple SclerosisDrug: ZenapaxNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years65 YearsBoth22Phase 2United States
1380NCT00010842September 199919 February 2015Natural Antioxidants in the Treatment of Multiple SclerosisNatural Antioxidants in the Treatment of Multiple SclerosisMultiple SclerosisDrug: Ginkgo biloba;Drug: Alpha-lipoic acid;Drug: Vitamin E/Selenium;Drug: Essential fatty acidsNational Center for Complementary and Integrative Health (NCCIH)Not recruitingN/AN/ABothPhase 1/Phase 2United States
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1381NCT00062972September 199916 December 2017Improving Memory in Patients With Multiple SclerosisInterventions to Improve Memory in Patients With Multiple SclerosisMultiple SclerosisDrug: donepezil;Drug: glucoseEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)U.S. Department of EducationNot recruiting18 Years56 YearsAll0Phase 3United States
1382NCT00473213September 199919 February 2015Optimizing IFN Beta - 1B DoseOptimizing IFN Beta - 1B DoseMultiple SclerosisDrug: Interferon Beta 1University of Turin, ItalyDimensione Ricerca s.r.l.Not recruiting18 Years50 YearsBoth217Phase 3
1383NCT00915460September 199919 February 2015Open-Label Safety Extension Study of AvonexAn Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830Multiple SclerosisDrug: Interferon beta-1a (Avonex)Biogen IdecNot recruitingN/AN/ABoth408Phase 4
1384NCT00219908July 199919 February 2015Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple SclerosisEvaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1bRelapsing-Remitting Multiple SclerosisDrug: MitoxantroneRennes University HospitalBayer;Wyeth is now a wholly owned subsidiary of Pfizer;Farmades, ItalyNot recruiting18 Years45 YearsBoth124Phase 2France;Italy
1385NCT00006060April 199919 February 2015Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple SclerosisMultiple SclerosisDrug: standard gadolinium contrastNational Center for Research Resources (NCRR)University of PennsylvaniaRecruiting20 Years70 YearsBoth100N/AUnited States
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1386NCT00040482April 199919 February 2015High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple SclerosisIntensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple SclerosisMultiple SclerosisDrug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapyBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineNot recruiting18 Years60 YearsBoth10Phase 2United States
1387NCT00220428July 199819 February 2015T-Cell Vaccination in Multiple Sclerosis (MS)The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy TrialMultiple SclerosisBiological: T-Cell VaccinationSheba Medical CenterRecruiting16 Years60 YearsBoth20Phase 1/Phase 2Israel
1388NCT00001781February 199819 February 2015Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS)Open-Label Baseline vs. Treatment Trial Evaluating the Safety, Tolerability and Effect on MRI Lesion and Immunology Parameters of CGP 77116 in Patients With Multiple Sclerosis MarkMultiple SclerosisDrug: CGP 77116National Institute of Neurological Disorders and Stroke (NINDS)Not recruitingN/AN/ABoth25Phase 2United States
1389NCT01257958February 199812 October 2015Vitamin D Pilot Study in Patients With Multiple SclerosisVitamin D Pilot Study in Patients With Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: 19 nor vitamin dUniversity of Wisconsin, MadisonNot recruiting18 Years45 YearsBothPhase 1United States
1390NCT00014755December 199719 February 2015Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple SclerosisMultiple SclerosisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Drug: prednisone;Procedure: peripheral blood stem cell transplantation;Procedure: irradiationFred Hutchinson Cancer Research CenterNot recruiting18 Years60 YearsBoth35Phase 1United States
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1391NCT00001669July 199719 February 2015A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) PatientsA 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) PatientsMultiple SclerosisDrug: rhIGF-1 (CEP-151)National Institute of Neurological Disorders and Stroke (NINDS)Not recruitingN/AN/ABoth15Phase 2United States
1392NCT00004816July 199519 February 2015A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple SclerosisMultiple SclerosisDrug: monoclonal antibody M-T412National Center for Research Resources (NCRR)Stanford UniversityNot recruiting21 Years75 YearsBoth25Phase 1
1393NCT00203021March 26, 199418 December 2018Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness.Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone®Multiple SclerosisDrug: Glatiramer acetateTeva Branded Pharmaceutical Products, R&D Inc.Not recruiting18 YearsN/AAll208Phase 4United States
1394NCT00004744February 199319 February 2015Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple SclerosisMultiple SclerosisDrug: immune globulinNational Institute of Neurological Disorders and Stroke (NINDS)Mayo ClinicNot recruiting18 Years60 YearsBoth76Phase 3
1395NCT00004814October 199119 February 2015Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: copolymer 1National Center for Research Resources (NCRR)University of MarylandNot recruiting18 Years45 YearsBoth250Phase 3
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
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PhaseCountries
1396NCT00000146July 198819 February 2015Optic Neuritis Treatment Trial (ONTT)Multiple Sclerosis;Optic NeuritisDrug: Methylprednisolone;Drug: PrednisoneNational Eye Institute (NEI)Not recruiting18 Years46 YearsBothPhase 3United States
1397NCT00000147July 198819 February 2015Longitudinal Optic Neuritis Study (LONS)Multiple Sclerosis;Optic NeuritisDrug: Methylprednisolone;Drug: PrednisoneNational Eye Institute (NEI)Not recruiting18 Years46 YearsBothN/AUnited States
1398JPRN-JapicCTI-05003123 April 2019Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)[Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injuryIntervention name : Baclofen
Dosage And administration of the intervention : Intertheacal injection
DAIICHI SANKYO COMPANY, LIMITEDBOTHPhase 4

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