13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | NCT04561557 (ClinicalTrials.gov) | September 22, 2020 | 10/9/2020 | Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System | An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System | Autoimmune Diseases;Autoimmune Diseases of the Nervous System;Neuromyelitis Optica Spectrum Disorder | Biological: CT103A cells;Drug: Cyclophosphamide and fludarabine | Tongji Hospital | Nanjing IASO Biotherapeutics Co.,Ltd | Recruiting | 18 Years | 75 Years | All | 12 | Early Phase 1 | China |
| 2 | EUCTR2019-001549-42-GB (EUCTR) | 27/03/2020 | 03/02/2020 | Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MS | A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS | Highly active relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide monohydrate INN or Proposed INN: Cyclophosphamide monohydrate Product Name: Filgrastim INN or Proposed INN: Filgrastim Trade Name: Thymoglobuline Product Name: Thymoglobuline INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin Trade Name: Alemtuzumab Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Product Name: Lenograstim INN or Proposed INN: Lenograstim Trade Name: Ocrelizumab Product Name: Ocrelizumab | Sheffield Teaching Hospitals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 198 | Phase 3 | United Kingdom | ||
| 3 | NCT03829566 (ClinicalTrials.gov) | November 2019 | 1/2/2019 | Autologous Transplant To End NMO Spectrum Disorder | Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica;Devic's Disease;NMO Spectrum Disorder | Drug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2/Phase 3 | United States |
| 4 | EUCTR2017-001362-25-NL (EUCTR) | 30/09/2019 | 10/09/2019 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Thymoglobuline® Product Name: Thymoglobuline® INN or Proposed INN: ANTITHYMOCYTE IMMUNOGLOBULIN Other descriptive name: ANTITHYMOCYTE IMMUNOGLOBULIN Trade Name: Lemtrada INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB Trade Name: Mavenclad Product Name: Cladribine INN or Proposed INN: CLADRIBINE Trade Name: Ocrevus Product Name: Ocrelizumab INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Denmark;Netherlands | ||
| 5 | EUCTR2017-001362-25-DK (EUCTR) | 27/06/2018 | 21/03/2018 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sendoxane Product Name: Cyclophosphamide Trade Name: Thymoglobuline® Product Name: Thymoglobuline® Trade Name: Lemtrada Product Name: alemtuzumab Trade Name: Sendoxane Product Name: Cyclophosphamide Trade Name: Mavenclad Product Name: Cladribine Trade Name: Ocrevus Product Name: Ocrelizumab | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Denmark;Netherlands | ||
| 6 | NCT03477500 (ClinicalTrials.gov) | March 21, 2018 | 13/2/2018 | RCT Comparing Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab in MS | Randomized Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab for Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide and ATG;Drug: Alemtuzumab | Haukeland University Hospital | NULL | Recruiting | 18 Years | 50 Years | All | 100 | Phase 3 | Denmark;Netherlands;Norway;Sweden |
| 7 | NCT03342638 (ClinicalTrials.gov) | November 8, 2017 | 9/11/2017 | Maximizing Outcome of Multiple Sclerosis Transplantation | Maximizing Outcome of Multiple Sclerosis Transplantation: MOST Trial | Multiple Sclerosis, Relapsing-Remitting | Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Terminated | 18 Years | 58 Years | All | 66 | Phase 3 | United States |
| 8 | NCT02529839 (ClinicalTrials.gov) | October 2015 | 10/6/2015 | Safety 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 Sclerosis | Multiple Sclerosis | Procedure: Autologous bone marrow transplantation;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Alemtuzumab | Hadassah Medical Organization | NULL | Not yet recruiting | 18 Years | 65 Years | Both | 20 | N/A | NULL |
| 9 | NCT01679041 (ClinicalTrials.gov) | November 2012 | 29/8/2012 | High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior Treatment | A Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of Therapy | Multiple Sclerosis | Drug: Alemtuzumab;Drug: Fludarabine;Drug: Cyclophosphamide | Seah Lim M.D. | NULL | Terminated | 18 Years | 60 Years | Both | 1 | Phase 2 | United States |
| 10 | EUCTR2010-023560-40-SE (EUCTR) | 23/03/2011 | 21/12/2010 | Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed. | Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST | Relapsing-remitting multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Sendoxan Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Thymoglobuline Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Neupogen Trade Name: Solu-Medrol | Uppsala l?ns landsting | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United States;Canada;Brazil;Sweden | |||
| 11 | NCT00939549 (ClinicalTrials.gov) | November 2010 | 14/7/2009 | High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis | Phase II Study of High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Cyclophosphamide/Glatiramer acetate | Johns Hopkins University | NULL | Withdrawn | 18 Years | 70 Years | All | 0 | Phase 2 | United States |
| 12 | EUCTR2007-000586-38-IT (EUCTR) | 21/12/2007 | 10/01/2008 | HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND | HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND | PATIENTS AFFECTED BY MULTIPLE SCLEROSIS MedDRA version: 6.1;Level: HLT;Classification code 10052785 | Trade Name: THIOPLEX INN or Proposed INN: Thiotepa Trade Name: ENDOXAN BAXTER INN or Proposed INN: Cyclophosphamide Trade Name: NEUPOGEN INN or Proposed INN: Filgrastim | OSPEDALE S. RAFFAELE | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Italy | ||
| 13 | EUCTR2006-002562-19-IT (EUCTR) | 21/04/2006 | 24/01/2007 | Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT | Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT | VERIFICARE 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 INN or Proposed INN: Antithymocyte Trade Name: Endoxan - ciclofosfamide Product Name: Endoxan INN or Proposed INN: Cyclophosfamide | Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di Genova | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Italy | |||
| 14 | NCT00241254 (ClinicalTrials.gov) | December 2005 | 17/10/2005 | Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis | A 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 Study | Multiple Sclerosis, Chronic Progressive | Drug: Cyclophosphamide (drug);Drug: Methylprednisolone (drug) | University Hospital, Bordeaux | Ministry of Health, France | Completed | 18 Years | 65 Years | Both | 138 | Phase 3 | France |
| 15 | NCT00296205 (ClinicalTrials.gov) | October 2003 | 23/2/2006 | Phase II High-Dose Cyclophosphamide for Multiple Sclerosis | Phase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide | Stony Brook University | NULL | Withdrawn | 18 Years | 75 Years | Both | 25 | Phase 2 | United States |
| 16 | NCT00017628 (ClinicalTrials.gov) | April 2001 | 6/6/2001 | Phase 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 Sclerosis | Multiple Sclerosis | Drug: cyclophosphamide;Drug: filgrastim;Drug: methylprednisolone;Procedure: Autologous Stem Cell Transplantation | Northwestern Memorial Hospital | NULL | Completed | N/A | 59 Years | Both | 20 | Phase 1 | United States | |
| 17 | NCT00040482 (ClinicalTrials.gov) | April 1999 | 26/6/2002 | High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis | Intensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapy | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Completed | 18 Years | 60 Years | All | 10 | Phase 2 | United States |
| 18 | NCT00014755 (ClinicalTrials.gov) | December 1997 | 10/4/2001 | Phase 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 Sclerosis | Multiple Sclerosis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Drug: prednisone;Procedure: peripheral blood stem cell transplantation;Procedure: irradiation | Fred Hutchinson Cancer Research Center | NULL | Completed | 18 Years | 60 Years | Both | 35 | Phase 1 | United States | |
| 19 | EUCTR2008-005773-35-IT (EUCTR) | 15/01/2013 | AUTOLOUGUS 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 SM | AUTOLOUGUS 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 SM | MULTIPLE 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 INN or Proposed INN: Cyclophosphamide Trade Name: FLUDARA INN or Proposed INN: Fludarabine Trade Name: THYMOGLOBULINE INN or Proposed INN: Antithymocyte immunoglobulin (rabbit) Trade Name: MABTHERA INN or Proposed INN: Rituximab | AZIENDA OSPEDALIERA DI PADOVA | NULL | NA | Female: yes Male: yes | Phase 1 | Italy |