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 | EUCTR2017-003008-30-GB (EUCTR) | 01/07/2020 | 17/05/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A 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 1.3 dated 23/05/18 | Multiple 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 INN or Proposed INN: Simvastatin | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | ||
| 2 | EUCTR2019-003127-38-NL (EUCTR) | 09/04/2020 | 09/04/2020 | Research on the effect of add-on high dosage simvastatin treatment on progression in MS patients treated with ocrelizumab and natalizumab. | Efficacy of add-on high dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial. - SIMSON trial | Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Simvastatin INN or Proposed INN: SIMVASTATIN Other descriptive name: Simvastatine | VUmc Neurology Department | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Netherlands | ||
| 3 | NCT04178980 (ClinicalTrials.gov) | January 1, 2020 | 25/11/2019 | Role of Simvastatin in Relapsing-Remitting Multiple Sclerosis | Double-blinded, Randomized Controlled Trial of Simvastatin Use As Adjuvant Therapy in Relapsing-Remitting Multiple Sclerosis | Simvastatin Multiple Sclerosis | Drug: Simvastatin in relapsing remitting multiple sclerosis | Assiut University | NULL | Not yet recruiting | 18 Years | 65 Years | All | 60 | Phase 1 | NULL |
| 4 | NCT03896217 (ClinicalTrials.gov) | May 16, 2019 | 26/10/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A 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 | Secondary Progressive Multiple Sclerosis | Drug: Simvastatin | University College, London | MS Society | Recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | United Kingdom |
| 5 | EUCTR2017-003328-56-GB (EUCTR) | 19/12/2017 | 31/10/2017 | MS-STAT2 - Multiple Sclerosis – Simvastatin Trial 2 | A 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-STAT2 | 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: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets INN or Proposed INN: Simvastatin Trade Name: Simvastatine Sandoz 40 mg filmomhulde tabletten Product Name: Simvastatine Sandoz 40 mg filmomhulde tabletten INN or Proposed INN: Simvastatin Trade Name: SimvaHEXAL® 40 mg Filmtabletten Product Name: SimvaHEXAL® 40 mg Filmtabletten INN or Proposed INN: Simvastatin Trade Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG Product Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG INN or Proposed INN: Simvastatin Trade Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película Product Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película INN or Proposed INN: Simvastatin Trade Name: Sivatin 40 mg film-coated tablets Product Name: Sivatin 40 mg film-coated tablets INN or Proposed INN: Simvastatin Trade Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten Product Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten INN or Proposed INN: Simvastatin | University College London Comprehensive Clinical Trials Unit | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1180 | Phase 3 | United Kingdom | ||
| 6 | EUCTR2006-001827-21-DK (EUCTR) | 06/03/2009 | 15/01/2009 | A 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 monthsStudy Phase: III - Simvastatin/Copaxone | A 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 monthsStudy Phase: III - Simvastatin/Copaxone | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Simvastatin Trade Name: Copaxone Product Name: Glatiramer acetate | Glostrup Hospital, Dep. of Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Denmark | ||||
| 7 | NCT00429442 (ClinicalTrials.gov) | March 2008 | 30/1/2007 | Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis | A 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 Months | Relapsing Remitting Multiple Sclerosis | Drug: Simvastatin;Drug: placebo | Anna Tsakiri | Sanofi | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 3 | Denmark |
| 8 | NCT00647348 (ClinicalTrials.gov) | January 2008 | 26/3/2008 | Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis | A Phase II Randomised, Placebo-controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis. | Secondary Progressive Multiple Sclerosis | Drug: Simvastatin;Drug: Placebo | Imperial College London | NULL | Completed | 18 Years | 65 Years | All | 140 | Phase 2 | United Kingdom |
| 9 | EUCTR2006-006347-31-GB (EUCTR) | 06/09/2007 | 07/08/2007 | A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis | A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis | Multiple 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) | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 10 | NCT00261326 (ClinicalTrials.gov) | September 2006 | 2/12/2005 | Simvastatin Treatment of Patients With Acute Optic Neuritis | Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial | Optic Neuritis;Multiple Sclerosis | Drug: simvastatin;Drug: placebo | Glostrup University Hospital, Copenhagen | Alpharma ApS | Active, not recruiting | 18 Years | 59 Years | Both | 64 | Phase 3 | Denmark |
| 11 | NCT00492765 (ClinicalTrials.gov) | February 2006 | 25/6/2007 | Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis | A 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 Sclerosis | Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: Simvastatin;Drug: Placebo | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 380 | Phase 4 | Denmark |
| 12 | EUCTR2005-003930-16-SE (EUCTR) | 19/01/2006 | 21/11/2005 | A 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 - SIMCOMBIN | A 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 - SIMCOMBIN | Patients 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 INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 13 | EUCTR2005-003930-16-FI (EUCTR) | 05/01/2006 | 29/11/2005 | A 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 - SIMCOMBIN | A 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 - SIMCOMBIN | Patients 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 have been prescribed treatment with Avonex. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Trade Name: Simvastatin Alternova Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 14 | EUCTR2005-003930-16-DK (EUCTR) | 09/12/2005 | 05/12/2005 | A 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 - SIMCOMBIN | A 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 - SIMCOMBIN | Patients 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 INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Denmark;Sweden | |||
| 15 | NCT00242268 (ClinicalTrials.gov) | October 2005 | 19/10/2005 | A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Simvastatin | Alabama Neurology Associates, PC | Biogen Idec | Recruiting | 18 Years | 55 Years | Both | 30 | Phase 3 | United States | |
| 16 | NCT00668343 (ClinicalTrials.gov) | April 2005 | 27/4/2008 | Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo | Relapsing Remitting Multiple Sclerosis | Drug: simvastatin;Drug: placebo | Tehran University of Medical Sciences | NULL | Completed | 15 Years | 60 Years | Both | 80 | Phase 3 | Iran, Islamic Republic of | |
| 17 | NCT00146068 (ClinicalTrials.gov) | September 2004 | 1/9/2005 | EARLY IFNB-1a and Simvastatin Combination Therapy in Clinically Isolated Syndrome Suggestive of Multiple Sclerosis | Phase 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 Period | Multiple Sclerosis | Drug: Avonex/Zocor | University of North Carolina | NULL | Completed | 18 Years | 60 Years | Both | 30 | Phase 4 | United States |