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


臨床試験数 : 3,342 薬物数 : 2,380 - (DrugBank : 407) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240

  
59 trials found
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1NCT05232825
(ClinicalTrials.gov)
March 31, 202227/1/2022A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple SclerosisA Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple SclerosisRelapsing Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Ocrelizumab IV;Drug: Ocrelizumab SC;Drug: Methylprednisolone IV;Drug: Diphenhydramine IV;Drug: Dexamethasone given orally;Drug: Desloratadine given orallyHoffmann-La RocheNULLNot yet recruiting18 Years65 YearsAll232Phase 3United States;Brazil;Canada;Czechia;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine
2NCT04979650
(ClinicalTrials.gov)
May 22, 20212/7/2021Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple SclerosisCorticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023Multiple Sclerosis, Relapsing-Remitting;Magnetic Resonance Imaging;MethylprednisoloneDrug: Methylprednisolone succinate;Drug: Normal salineMazandaran University of Medical SciencesNULLEnrolling by invitation18 Years55 YearsAll104Phase 2Iran, Islamic Republic of
3NCT04688788
(ClinicalTrials.gov)
April 28, 202122/12/2020Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple SclerosisDanish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple SclerosisRelapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Rituximab;Drug: Ocrelizumab;Drug: Fexofenadine;Drug: Paracetamol;Drug: MethylprednisoloneRigshospitalet, DenmarkOdense University Hospital;Aarhus University Hospital;Aalborg University Hospital;Herlev Hospital;Hillerod Hospital, Denmark;Zealand University Hospital;Kolding Sygehus;Regional Hospital Holstebro;Hvidovre University Hospital;Hospital of South West Jutland, Esbjerg, Denmark;GCP unit, Copenhagen University Hospital;GCP-unit at Aarhus University Hospital, Aarhus, Denmark;Hospital of Southern Jutland, Sønderborg, Denmark;Hospital of Central Denmark Region, Viborg, Denmark;Danske RegionerRecruiting18 Years65 YearsAll594Phase 3Denmark
4NCT04548999
(ClinicalTrials.gov)
December 3, 20209/9/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: Antihistamine;Drug: MethylprednisoloneHoffmann-La RocheNULLRecruiting18 Years55 YearsAll699Phase 3United States;Argentina;Belgium;Brazil;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Peru;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
5NCT04544436
(ClinicalTrials.gov)
November 26, 20204/9/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: Antihistamine;Drug: MethylprednisoloneHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll786Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czechia;Israel;Mexico;Netherlands
6NCT04601142
(ClinicalTrials.gov)
October 31, 202015/10/2020Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene PolymorphismStudy on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort StudyGlucocorticoid Resistance;Gene;Neuromyelitis OpticaDrug: MethylprednisoloneBeijing Tongren HospitalNULLRecruiting16 Years80 YearsAll350China
7NCT04832269
(ClinicalTrials.gov)
October 19, 202018/2/2021Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and BehaviourEffects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain DevelopmentMultiple SclerosisOther: Exposure to methylprednisolone during pregnancyJena University HospitalRuhr University of Bochum;Interdisciplinary Center of Clinical Research of the Medical Faculty Jena;Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyRecruiting8 Years18 YearsAll80Germany
8EUCTR2018-000620-34-DE
(EUCTR)
06/05/202008/11/2019Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
INN or Proposed INN: IMATINIB MESILATE
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Department of Clinical Neuroscience, Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Germany;Sweden
9NCT03829566
(ClinicalTrials.gov)
November 20191/2/2019Autologous Transplant To End NMO Spectrum DisorderAutologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Devic's Disease;NMO Spectrum DisorderDrug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLWithdrawn18 Years65 YearsAll0Phase 2/Phase 3United States
10NCT03674099
(ClinicalTrials.gov)
October 1, 201814/9/2018Imatinib for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised StudyMultiple SclerosisDrug: Imatinib Mesylate;Drug: MethylprednisoloneTomas OlssonThe Swedish Research CouncilRecruiting18 Years55 YearsAll200Phase 2Denmark;Germany;Norway;Sweden
11EUCTR2017-000635-13-DE
(EUCTR)
08/06/201822/02/2018Escalating 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 immunoadsorption Multiple 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]
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Universität LeipzigNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Germany
12EUCTR2018-000620-34-SE
(EUCTR)
24/04/201814/03/2018Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
INN or Proposed INN: IMATINIB MESILATE
Trade Name: Solu-Medrol
Product Name: Solu-Medrol
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Department of Clinical Neuroscience, Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Sweden
13NCT03387046
(ClinicalTrials.gov)
March 26, 201822/12/2017A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE)Multiple Sclerosis, Relapsing-RemittingDietary Supplement: D-aspartate;Drug: Placebo;Biological: IFN beta-1a;Drug: MethylprednisoloneMerck KGaA, Darmstadt, GermanyNULLTerminated18 Years55 YearsAll7Phase 2Italy;Germany
14NCT03342638
(ClinicalTrials.gov)
November 8, 20179/11/2017Maximizing Outcome of Multiple Sclerosis TransplantationMaximizing Outcome of Multiple Sclerosis Transplantation: MOST TrialMultiple Sclerosis, Relapsing-RemittingDrug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years58 YearsAll66Phase 3United States
15NCT03368664
(ClinicalTrials.gov)
October 24, 20172/11/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)Multiple SclerosisDrug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonistGenzyme, a Sanofi CompanyNULLActive, not recruiting10 Years17 YearsAll50Phase 3Austria;Belgium;France;Italy;Netherlands;Poland;Portugal;Russian Federation;Turkey;United Kingdom;Bulgaria;Czechia;Germany;Greece;Norway;Spain;Switzerland
16NCT02784210
(ClinicalTrials.gov)
October 5, 201626/5/2016Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis PlaquesThe Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded StudyMultiple SclerosisDrug: Methylprednisolone;Drug: PrednisoneNational Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll30Phase 2United States
17NCT02769689
(ClinicalTrials.gov)
April 201617/3/2016Methylprednisolone 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-FerrandNULLRecruiting18 Years65 YearsBoth56Phase 4France
18NCT02583594
(ClinicalTrials.gov)
December 6, 201516/10/2015A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple SclerosisA Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: DexchlorpheniramineGenzyme, a Sanofi CompanyNULLCompleted18 YearsN/AAll24Phase 1Spain
19NCT02545959
(ClinicalTrials.gov)
November 30, 20157/9/2015Intrathecal Rituximab in Progressive Multiple SclerosisIntrathecal Rituximab in Progressive Multiple SclerosisMultiple Sclerosis, Chronic Progressive;Nervous System DiseasesDrug: Rituximab IT;Drug: methylprednisolone IV;Drug: Rituximab IVCentre Hospitalier de PAUUniversity Hospital, BordeauxCompleted45 YearsN/AAll10Phase 2France
20EUCTR2014-005493-11-FR
(EUCTR)
31/08/201515/03/2018Study the action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action in patients with Progressive Multiple Sclerosis.Intrathecal Rituximab in Progressive Multiple Sclerosis - EFFRITE Patients included in our study suffer from a progressive form of Multiple sclerosis and will be treated by intravenous and intrathecal rituximab, with intravenous methylprednisolone.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Méthylprednisolone Mylan
Product Name: méthylprednisolone
Trade Name: Mabthera
Product Name: rituximab
Trade Name: Mabthera
Product Name: rituximab
Centre Hospitalier de PauNULLNot Recruiting Female: yes
Male: yes
12 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
21NCT02398994
(ClinicalTrials.gov)
March 201523/3/2015A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse MyelitisA Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and ChildrenMyelitis, Transverse;Neuromyelitis OpticaDrug: Intravenous Methylprednisolone;Drug: Intravenous ImmunoglobulinGuy's and St Thomas' NHS Foundation TrustKing's College London;Barts and the London School of Medicine and Dentistry;Cardiff University;University College, London;King's College Hospital NHS Trust;Great Ormond Street Hospital for Children NHS Foundation Trust;Barts & The London NHS Trust;Alder Hey Children's NHS Foundation Trust;Walton Centre NHS Foundation Trust;Oxford University Hospitals NHS Trust;Birmingham Children's Hospital NHS Foundation Trust;University Hospital Birmingham NHS Foundation Trust;Cardiff and Vale University Health Board;North Bristol NHS Trust;University Hospitals Bristol NHS Foundation Trust;Central Manchester University Hospitals NHS Foundation Trust;Salford Royal NHS Foundation Trust;University Hospital Southampton NHS Foundation Trust.;Newcastle-upon-Tyne Hospitals NHS Trust;Nottingham University Hospitals NHS Trust;NHS LothianTerminated1 YearN/ABoth2Phase 3United Kingdom
22NCT02205489
(ClinicalTrials.gov)
October 201429/7/2014Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADASingle Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADARelapsing-remitting Multiple SclerosisDrug: Alemtuzumab GZ402673;Drug: cetirizine;Drug: ranitidine;Drug: methylprednisolone;Drug: aciclovir;Drug: esomeprazole;Drug: ibuprofen;Drug: paracetamolGenzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth58Phase 4Belgium;France;Netherlands;Spain
23NCT02087813
(ClinicalTrials.gov)
March 201411/3/2014Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica RelapsesA Single Center Open Label Pilot Study of Alpha1-Antitrypsin: A Novel Treatment to Mitigate Neuromyelitis Optica AttacksNeuromyelitis OpticaDrug: Alpha1-antitrypsin;Drug: methylprednisoloneStanford UniversityNULLWithdrawn18 Years75 YearsAll0Phase 1United States
24NCT02048358
(ClinicalTrials.gov)
November 201317/1/2014Safety, 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.NULLTerminated18 Years65 YearsBoth47Phase 1Netherlands
25NCT01986998
(ClinicalTrials.gov)
October 201311/1/2013Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in RelapseMulticenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse.Multiple SclerosisDrug: Methylprednisolone 1250 mg/24h x3 days;Drug: Oral Methylprednisolone 625 mg/24h x3 daysGermans Trias i Pujol HospitalNULLCompleted18 Years59 YearsBoth49Phase 4Spain
26EUCTR2012-004807-10-DE
(EUCTR)
17/07/201326/10/2012Relapse 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 Neuritis MS 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;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;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
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
University Medical Center Hamburg EppendorfNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Germany
27NCT01710228
(ClinicalTrials.gov)
July 20134/9/2012Alternative Treatment Paradigm for Natalizumab TrialAlternative Treatment Paradigm for Natalizumab TrialMultiple Sclerosis (MS)Drug: methylprednisoloneUniversity of Texas Southwestern Medical CenterTeva Pharmaceutical Industries;The University of Texas Health Science Center, Houston;University of Alabama at Birmingham;Charite University, Berlin, GermanyWithdrawn18 Years60 YearsBoth0Phase 2United States
28NCT01900093
(ClinicalTrials.gov)
July 201311/7/2013Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS RelapsesAn Open-Label Prospective Proof-Of-Concept Trial to Evaluate the Response to Acthar Gel Therapy in Patients With Multiple Sclerosis (MS) Relapses Who Have Failed To Make an Adequate Recovery After Treatment With High-Dose Intravenous MethylprednisoloneMultiple SclerosisDrug: Acthar GelAaron MillerMallinckrodtRecruiting18 Years65 YearsAll10N/AUnited States
29NCT01838174
(ClinicalTrials.gov)
May 201318/4/2013A Trial of Neuroprotection With ACTH in Acute Optic NeuritisA Phase IV Trial of Neuroprotection With ACTH in Acute Optic NeuritisMultiple SclerosisDrug: ACTHAR Gel (ACTH);Drug: IV methylprednisolone (steroids)University of Colorado, DenverMallinckrodt;University of PennsylvaniaTerminated18 Years55 YearsAll100Phase 4United States
30EUCTR2012-001965-34-ES
(EUCTR)
07/11/201209/08/2012Study 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
Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE
Servicio de Neurología, HU. Germans Trias i PujolNULLNot RecruitingFemale: yes
Male: yes
Phase 4Spain
31EUCTR2010-024561-43-DK
(EUCTR)
24/05/201107/02/2011Cyclic Oral Methylprednisolone Trial in Multiple SclerosisCyclic Oral Methylprednisolone Trial in Multiple Sclerosis progressive 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
Other descriptive name: METHYLPREDNISOLONE
Scleroseklinikken, RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
30Denmark
32NCT01305837
(ClinicalTrials.gov)
April 201128/2/2011Cyclic Oral Methylprednisolone Trial in Multiple SclerosisCyclic Oral Methylprednisolone Trial in Multiple SclerosisProgressive Multiple SclerosisDrug: methylprednisoloneRigshospitalet, DenmarkNULLCompleted18 Years65 YearsBoth30Phase 2Denmark
33EUCTR2009-013884-21-PL
(EUCTR)
20/05/201013/01/2010A 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: 14.1;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: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Germany;Belgium;Poland
34EUCTR2009-017490-38-DE
(EUCTR)
03/05/201001/02/2010Randomized Treatment Interruption of Natalizumab - RESTORERandomized Treatment Interruption of Natalizumab - RESTORE Natalizumab 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
INN or Proposed INN: NATALIZUMAB
Other descriptive name: TYSABRI
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: COPAXONE
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: AVONEX
Trade Name: Urbason Forte
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: URBASON FORTE
Biogen IdecNULLNot RecruitingFemale: yes
Male: yes
200Germany;Spain
35NCT01071083
(ClinicalTrials.gov)
March 201017/2/2010Treatment Interruption of NatalizumabRandomized Treatment Interruption of NatalizumabRelapsing Remitting Multiple SclerosisDrug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetateBiogenElan PharmaceuticalsCompleted18 Years60 YearsAll175Phase 2United States;Germany;Spain
36NCT01039103
(ClinicalTrials.gov)
December 200920/12/2009Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)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)Acute Exacerbation of Remitting Relapsing Multiple Sclerosis;Clinically Isolated SyndromeDrug: PEG-liposomal prednisolone sodium phosphate;Drug: MethylprednisoloneGalapagos NVNULLTerminated18 Years65 YearsBoth15Phase 2Belgium;Germany;Poland
37EUCTR2009-013884-21-DE
(EUCTR)
18/11/200909/09/2009A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Poland;Belgium;Germany
38EUCTR2009-013884-21-BE
(EUCTR)
13/11/200910/09/2009A 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: 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: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Poland;Belgium;Germany
39NCT01049451
(ClinicalTrials.gov)
November 200913/1/2010Pulse ACTH vs. MP for MSComparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif)Multiple SclerosisDrug: ACTH;Drug: MethylprednisoloneUniversity of Southern CaliforniaNULLCompleted18 Years65 YearsAll23Phase 1United States
40NCT00947895
(ClinicalTrials.gov)
October 20092/7/2009Efficacy 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.MallinckrodtTerminated18 YearsN/ABoth30Phase 2/Phase 3United States
41EUCTR2009-011516-37-DK
(EUCTR)
29/05/200915/05/2009Double 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-ProgMS Multiple Sclerosis, with primary and secondary progressive courses.
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: NeoRecormon
INN or Proposed INN: Solu-Medrol
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Danish Multiple Sclerosis Research CentreNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
42NCT00764413
(ClinicalTrials.gov)
April 20091/10/2008Chronotherapy 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 HFNULLTerminated18 YearsN/ABoth57N/ANorway
43EUCTR2008-005304-93-GB
(EUCTR)
13/02/200912/12/2008A 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 sclerosis Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease.
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
MedDRA version: 9.1;Classification code 10065687;Term: Bone loss
Trade Name: Aclasta 5mg solution for infusion
Product Name: Aclasta
Product Code: ZOL446H
North Bristol TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
44NCT00753792
(ClinicalTrials.gov)
November 200816/9/2008Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During RelapseMulticenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During RelapseMultiple SclerosisDrug: methylprednisolone;Drug: PlaceboGermans Trias i Pujol HospitalNULLCompleted18 Years59 YearsBoth49Phase 4Spain
45EUCTR2007-000888-15-ES
(EUCTR)
19/05/200827/02/2008ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis MúltipleENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple Pacientes afectos de esclerosis múltiple
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: SOLU-MODERIN 1 g
INN or Proposed INN: METHYLPREDNISOLONE
Trade Name: URBASON 40 mg comprimidos
INN or Proposed INN: METHYLPREDNISOLONE
Servicio de NeurologíaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
46EUCTR2007-002179-15-FR
(EUCTR)
04/03/200822/11/2007Etude 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 - CORTICOFLASH Méthylprednisolone administrée aux patients et contrôles à la dose de 1g/j pendant 3 jours, comme prescrit habituellement dans le cadre de leur pathologie.
MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
47NCT00984984
(ClinicalTrials.gov)
March 200824/9/2009Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) RelapsesRandomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis RelapsesMultiple Sclerosis, Relapsing-RemittingDrug: methylprednisolone PO;Drug: methylprednisolone IVRennes University HospitalNULLRecruiting18 Years55 YearsBoth200Phase 3France
48EUCTR2007-000590-37-FR
(EUCTR)
17/07/200723/05/2007Etude 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 - COPOUSEP Traitement des poussées de sclérose en plaques
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: METHYLPREDNISOLONE
INN or Proposed INN: METHYLPREDNISOLONE
Trade Name: methylprednisolone
Product Name: methylprednisolone
Trade Name: methylprednisolone
Product Name: methylprednisolone
CHU RennesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
49EUCTR2005-005592-14-DE
(EUCTR)
27/07/200612/05/2006Double blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision ProtectDouble blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision Protect Multiple sclerosis (MS) is a chronic disease of the central nervous system.Optic neuritis represents one of the most common and frequently the first clinical manifestation of MS. Optic neuritis is mainly characterized by a subacute loss of vision.Trade Name: Erypo/Erypo FS
Product Name: Erypo/Erypo FS
INN or Proposed INN: Epoetin alfa
Other descriptive name: Epo
Trade Name: Urbason solubile forte 1000mg
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolon-21-hydrogensuccinat, Natriumsalz
IFSgGmbH, Institute for clinical researchNULLNot RecruitingFemale: yes
Male: yes
Germany
50NCT00241254
(ClinicalTrials.gov)
December 200517/10/2005Efficacy 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, FranceCompleted18 Years65 YearsBoth138Phase 3France
51NCT00493116
(ClinicalTrials.gov)
October 200325/6/2007Is 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 IdecNULLCompleted18 Years55 YearsBoth20Phase 4Australia;New Zealand
52NCT00418145
(ClinicalTrials.gov)
September 20032/1/2007Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis AttacksOral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)Multiple SclerosisDrug: megadose oral methylprednisolone;Drug: IV methylprednisoloneFred LublinNational Multiple Sclerosis Society;PfizerTerminated18 Years50 YearsAll16Phase 3United States
53NCT00112034
(ClinicalTrials.gov)
June 200327/5/2005AVONEX® 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 IdecNULLCompleted18 Years55 YearsBoth350Phase 4United States
54NCT00492466
(ClinicalTrials.gov)
March 200325/6/2007Investigating 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 IdecNULLCompleted18 Years55 YearsBoth14Phase 4Finland
55NCT00168766
(ClinicalTrials.gov)
January 200313/9/2005Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MSA Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: Interferon-beta-1a (Avonex) plus methylprednisoloneBiogen IdecNULLCompleted18 Years55 YearsBoth345Phase 4Belgium;Denmark;Finland;Netherlands;Norway;Sweden;Switzerland;United Kingdom
56NCT00037115
(ClinicalTrials.gov)
May 200215/5/2002Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event.An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results.Demyelinating Disorders;Multiple Sclerosis;Optic Neuritis;Myelitis;NeuritisDrug: interferon beta 1a;Drug: methotrexate;Drug: methylprednisoloneMidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteConsultants in NeurologyWithdrawn18 Years50 YearsAll0Phase 4United States
57NCT00017628
(ClinicalTrials.gov)
April 20016/6/2001Phase 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 HospitalNULLCompletedN/A59 YearsBoth20Phase 1United States
58NCT00000147
(ClinicalTrials.gov)
July 198823/9/1999Longitudinal Optic Neuritis Study (LONS)Multiple Sclerosis;Optic NeuritisDrug: Methylprednisolone;Drug: PrednisoneNational Eye Institute (NEI)NULLActive, not recruiting18 Years46 YearsBothN/AUnited States
59NCT00000146
(ClinicalTrials.gov)
July 198823/9/1999Optic Neuritis Treatment Trial (ONTT)Multiple Sclerosis;Optic NeuritisDrug: Methylprednisolone;Drug: PrednisoneNational Eye Institute (NEI)NULLActive, not recruiting18 Years46 YearsBothPhase 3United States