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 | EUCTR2012-000635-68-IE (EUCTR) | 19/09/2012 | 09/02/2012 | An initial, short-duration study of vitamin D versus an inactive therapy on the ability of the human immune system to counteract the effects of Multiple Sclerosis on the brain and the effects of vitamin D on the immune system in healthy individuals. | Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome or early multiple sclerosis and healthy control participants. An exploratory randomised double blind placebo controlled study - N/A | Multiple Sclerosis MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Product Name: N/A Product Code: N/A | University College Dublin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Ireland | |||
| 2 | EUCTR2010-020328-23-PT (EUCTR) | 06/01/2012 | 17/11/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.0;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: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA - Geneva, an affiliate of Merck KGaA | ,NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 3 | EUCTR2010-020328-23-AT (EUCTR) | 23/11/2011 | 28/10/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;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: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA - Geneva, an affiliate of Merck KGaA | ,NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 4 | EUCTR2011-002785-20-DE (EUCTR) | 19/09/2011 | 11/08/2011 | Efficacy of Vitamin D Supplementation in relapsing-remitting Multiple Sclerosis | Efficacy of Vitamin D Supplementation in relapsing-remitting Multiple Sclerosis - EVIDIMS | Multiple Sclerosis and Clinical isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol® Öl 20.000 I.E./ml Product Name: Vigantol® Öl 20.000 I.E./ml Product Code: Vigantol® Öl 20.000 I.E./ml INN or Proposed INN: COLECALCIFEROL Trade Name: Dekristol®-Tablette 1 (400 IE) Product Name: Dekristol® 400-Tabletten Product Code: Dekristol® 400-Tabletten INN or Proposed INN: COLECALCIFEROL Other descriptive name: 25OH-Vitamin D | Charité - Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
| 5 | EUCTR2010-020328-23-LV (EUCTR) | 19/07/2011 | 16/05/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.0;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: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Latvia;Norway;Germany;Netherlands | ||
| 6 | EUCTR2010-020328-23-LT (EUCTR) | 09/05/2011 | 02/03/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;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: Vigantol Oil Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 7 | EUCTR2010-020328-23-EE (EUCTR) | 26/04/2011 | 21/03/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;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: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 8 | EUCTR2010-020328-23-BE (EUCTR) | 01/04/2011 | 18/11/2010 | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA-Geneva an affiliate of Merck KgaA, Darmstadt | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 9 | EUCTR2010-020328-23-IT (EUCTR) | 10/03/2011 | 07/02/2011 | A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR | A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR | RELAPSING REMITTING MULTIPLE SCLEROSIS MedDRA version: 9.1;Level: PT;Classification code 10063399 | Trade Name: VIGANTOL OIL INN or Proposed INN: Colecalciferol | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 10 | NCT01285401 (ClinicalTrials.gov) | February 2011 | 26/1/2011 | Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment | A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif® | Relapsing-Remitting Multiple Sclerosis | Drug: VigantOL oil plus interferon beta-1a (Rebif);Drug: Placebo plus interferon beta-1a (Rebif);Biological: Interferon beta-1a (Rebif®) alone | Merck KGaA | NULL | Completed | 18 Years | 55 Years | All | 260 | Phase 2 | Austria;Denmark;Estonia;Finland;Germany;Italy;Latvia;Lithuania;Netherlands;Norway;Portugal;Switzerland;Belgium;Hungary |
| 11 | EUCTR2010-020328-23-DE (EUCTR) | 31/01/2011 | 27/10/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis 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] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Italy;Switzerland;Belgium;Denmark;Germany;Latvia;Netherlands;Norway | ||
| 12 | EUCTR2010-020328-23-NL (EUCTR) | 06/01/2011 | 16/09/2010 | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono The Netherlands - a division of Merck B.V. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 13 | EUCTR2010-020328-23-DK (EUCTR) | 09/12/2010 | 08/11/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;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: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 14 | EUCTR2010-020328-23-FI (EUCTR) | 21/10/2010 | 27/08/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;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: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 15 | EUCTR2014-000728-97-NL (EUCTR) | 08/05/2014 | Regulation of the stress-axis by vitamin D in subjects with multiple sclerosis. | Regulation of the stress-axis by vitamin D3 in subjects with multiple sclerosis; a double-blinded, randomized, placebo-controlled study - Vitamin D3 and the stress-axis in MS | Relapsing remitting multiple sclerosis 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] - Nervous System Diseases [C10] | Trade Name: Vigantol® Oil Product Name: Vigantol® Oil Product Code: EMD 28162 | Academic MS Center Limburg | NULL | Not Recruiting | Female: yes Male: no | Phase 2 | Netherlands |