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 |
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1 | EUCTR2021-000048-23-DE (EUCTR) | 03/03/2022 | 07/10/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;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: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | United States;Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
2 | EUCTR2021-000048-23-NL (EUCTR) | 10/02/2022 | 12/10/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;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: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;United States;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
3 | EUCTR2021-000028-36-BG (EUCTR) | 18/01/2022 | 08/11/2021 | Not applicable | A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 Product Name: Vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1050 | Phase 3 | United States;Belarus;Greece;Ukraine;Lithuania;North Macedonia;Russian Federation;Colombia;India;Mexico;Poland;Bulgaria;Albania;Georgia;Moldova, Republic of | ||
4 | EUCTR2021-000048-23-BG (EUCTR) | 28/10/2021 | 28/09/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;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: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
5 | EUCTR2018-001896-19-BG (EUCTR) | 17/12/2018 | 11/10/2018 | 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) | 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) - EMPhASIS | 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] | Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | Poland;Ukraine;Romania;Bulgaria | ||
6 | NCT02636829 (ClinicalTrials.gov) | March 2016 | 17/11/2015 | Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis | Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis | Multiple Sclerosis;Rheumatoid Arthritis | Other: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interview | Centre Hospitalier Universitaire de Nimes | NULL | Completed | 18 Years | 69 Years | Both | 100 | N/A | France |
7 | NCT01166178 (ClinicalTrials.gov) | October 2010 | 19/7/2010 | Zoledronic Acid in MS-patients With Osteoporosis | A 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 | Osteoporosis;Multiple Sclerosis | Drug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combination | Novartis | NULL | Terminated | 18 Years | 75 Years | All | 29 | Phase 3 | Germany |
8 | NCT00785473 (ClinicalTrials.gov) | January 2008 | 4/11/2008 | Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis | Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study | Multiple Sclerosis, Osteoporosis | Dietary Supplement: cholecalciferol;Dietary Supplement: calcium carbonate | University Hospital of North Norway | NULL | Completed | 18 Years | 50 Years | Both | 80 | Phase 4 | Norway |
9 | NCT00644904 (ClinicalTrials.gov) | July 2006 | 24/3/2008 | Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis | A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: Vitamin D3 | University of Toronto | Direct MS-Proactive Charity;Multiple Sclerosis Society of Canada | Completed | 18 Years | 55 Years | Both | 49 | Phase 1/Phase 2 | Canada |
10 | EUCTR2005-006071-12-IT (EUCTR) | 31/08/2005 | 09/05/2006 | Evaluation 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 - ADVANCE | Evaluation 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 - ADVANCE | MULTIPLE SCLEROSIS MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: EPARMEFOLIN 30 CPR 0,1/0,5MG INN or Proposed INN: CALCIO FOLINATO DC.IT INN or Proposed INN: CIANOCOBALAMINA FU DC.IT Trade Name: LEVOFOLENE 4 MG 30 CPR INN or Proposed INN: Calcium levofolinate | AZIENDA OSPEDALIERA SAN CAMILLO FORLANINI | NULL | Not Recruiting | Female: yes Male: yes | 276 | Italy |