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 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05359653 (ClinicalTrials.gov) | March 22, 2023 | 28/4/2022 | Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy | A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy | Multiple Sclerosis (MS);Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic Progressive;Multiple Sclerosis Relapse;Multiple Sclerosis Brain Lesion;Multiple Sclerosis Benign | Drug: Clemastine Fumarate;Drug: Placebo | University of California, San Francisco | United States Department of Defense | Not yet recruiting | 18 Years | 55 Years | All | 74 | Phase 1/Phase 2 | United States |
| 2 | NCT05177718 (ClinicalTrials.gov) | September 16, 2022 | 13/12/2021 | Natalizumab and Chronic Inflammation | Assessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin Integrity | Multiple Sclerosis | Drug: Natalizumab 300 MG in 15 ML Injection | Vanderbilt University Medical Center | Biogen | Recruiting | 18 Years | 65 Years | All | 36 | Phase 4 | United States |
| 3 | NCT03910738 (ClinicalTrials.gov) | October 29, 2019 | 1/4/2019 | TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis | TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: 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 disability | University Hospital, Strasbourg, France | Bayer;Fédération Hospitalo-Universitaire NEUROGENYCS | Recruiting | 18 Years | 55 Years | Male | 40 | Phase 2 | France |
| 4 | NCT03774407 (ClinicalTrials.gov) | June 20, 2019 | 5/12/2018 | Vaginal Estriol in Multiple Sclerosis | Dual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis;Neurogenic Bladder | Drug: vaginal estriol | Texas Tech University Health Sciences Center | NULL | Completed | 40 Years | 65 Years | Female | 21 | Phase 2/Phase 3 | United States |
| 5 | NCT02903537 (ClinicalTrials.gov) | July 6, 2017 | 21/7/2016 | Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS) | Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS) | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Chronic Progressive | Drug: Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3);Drug: Interferon-beta | Fundació Institut Germans Trias i Pujol | Clinica Universidad de Navarra, Universidad de Navarra | Recruiting | 18 Years | 60 Years | All | 16 | Phase 1 | Spain |
| 6 | EUCTR2016-002180-33-PL (EUCTR) | 16/11/2016 | 14/07/2016 | Multiple sclerosis therapy with transdermal myelin peptide stimulation. | Multiple sclerosis therapy with transdermal myelin peptide stimulation. | relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: Avonex INN or Proposed INN: Interferon beta 1-A Other descriptive name: INTERFERON BETA-1A | Centrum Neurologii Krzysztof Selmaj | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 2 | Poland | ||
| 7 | NCT02446886 (ClinicalTrials.gov) | June 2016 | 7/5/2015 | Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS | Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS | Multiple Sclerosis | Drug: Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®) | Weill Medical College of Cornell University | Mallinckrodt | Completed | 18 Years | N/A | All | 15 | Phase 4 | United States |
| 8 | NCT02283671 (ClinicalTrials.gov) | September 2015 | 29/10/2014 | Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B | Multiple Sclerosis;Neuromyelitis Optica | Biological: Tolerogenic Dendritic cells loaded with myelin peptides | Sara Varea | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 1 | Spain | |
| 9 | NCT02427776 (ClinicalTrials.gov) | January 2015 | 2/4/2015 | A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis | A 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-Remitting | Biological: Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope | Imcyse SA | NULL | Terminated | 18 Years | 50 Years | All | 2 | Phase 1/Phase 2 | Belgium |
| 10 | EUCTR2014-001081-99-BE (EUCTR) | 16/12/2014 | 03/12/2014 | A 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 sclerosis | A 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 Trial | Multiple 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 INN or Proposed INN: Cytolytic CD4+ T cells Other descriptive name: AUTOLOGOUS T-LYMPHOCYTES | ImCyse S.A | NULL | Not Recruiting | Female: yes Male: yes | Phase 1;Phase 2 | Belgium | |||
| 11 | NCT02142764 (ClinicalTrials.gov) | November 2014 | 15/5/2014 | Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients | Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS). | Multiple Sclerosis | Biological: Blood samples | University Hospital, Bordeaux | Merck Serono International SA;ADERA | Completed | 18 Years | N/A | Both | 30 | N/A | France |
| 12 | EUCTR2008-004408-29-DE (EUCTR) | 27/11/2009 | 31/07/2008 | ESTABLISH 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 - - ETIMS | ESTABLISH 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 - - ETIMS | relapsing-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 | University Medical Center Hamburg-Eppendorf | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Germany | |||
| 13 | EUCTR2005-001340-22-CZ (EUCTR) | 09/04/2006 | 30/08/2005 | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | Multiple 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 | Bayhill Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 252 | Finland;United Kingdom;Czech Republic | |||
| 14 | EUCTR2005-005211-21-FI (EUCTR) | 17/01/2006 | 07/12/2005 | A long term follow up of relapsing remitting multiple sclerosis patients who have been treated with intereron beta -1b (Betaferon) at least 5 years | A long term follow up of relapsing remitting multiple sclerosis patients who have been treated with intereron beta -1b (Betaferon) at least 5 years | Remitting 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 INN or Proposed INN: Beta-1b interferoni | Schering Oy | NULL | Not Recruiting | Female: yes Male: yes | 80 | Finland | |||
| 15 | EUCTR2005-001340-22-FI (EUCTR) | 29/11/2005 | 22/07/2005 | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | Multiple 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 | Bayhill Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 252 | Finland;Czech Republic;United Kingdom | |||
| 16 | EUCTR2005-001340-22-SK (EUCTR) | 27/09/2005 | 29/07/2005 | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | Multiple 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 | Bayhill Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | Czech Republic;Slovakia;Finland;United Kingdom | ||
| 17 | EUCTR2005-001340-22-GB (EUCTR) | 12/08/2005 | 18/07/2005 | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | Multiple 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 | Bayhill Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Finland;Czech Republic;United Kingdom | |||
| 18 | EUCTR2004-000663-99-HU (EUCTR) | 08/11/2004 | 08/09/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Sweden | |||
| 19 | EUCTR2004-000663-99-CZ (EUCTR) | 12/10/2004 | 22/10/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Czech Republic;Sweden | |||
| 20 | EUCTR2004-000663-99-SE (EUCTR) | 10/09/2004 | 03/08/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Sweden | |||
| 21 | NCT01448252 (ClinicalTrials.gov) | May 2002 | 5/10/2011 | T Cell Vaccination in Patients With Progressive Multiple Sclerosis | Autologous T Cell Vaccination With Line Specific for 9 Myelin Peptides in Patients With Progressive / Relapsing Multiple Sclerosis | Multiple Sclerosis | Biological: multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides);Biological: T cell vaccination | Hadassah Medical Organization | NULL | Completed | 18 Years | 60 Years | Both | 30 | Phase 1/Phase 2 | Israel |