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 | EUCTR2012-004602-97-ES (EUCTR) | 11/01/2013 | 12/11/2012 | ?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial? | ?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial? - VITADEM | RELAPSING-REMITING 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: VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA INN or Proposed INN: COLECALCIFEROL Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM) | Javier Olascoaga Urtaza | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain | ||
| 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-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 | ||
| 7 | EUCTR2010-023677-19-IT (EUCTR) | 23/03/2011 | 10/06/2011 | Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010 | Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010 | PATIENT WITH RRMS AND SPMS MedDRA version: 13.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders | Trade Name: BETAFERON*15CONFEZ 0,25MG/ML+ INN or Proposed INN: Interferon beta-1b Trade Name: EXTAVIA*SC 15FL 250MCG/ML+15SI INN or Proposed INN: Interferon beta-1b Trade Name: DIBASE INN or Proposed INN: Colecalciferol | AZIENDA OSPEDALIERA S. LUIGI GONZAGA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | EUCTR2009-013695-46-FR (EUCTR) | 22/10/2009 | 07/09/2009 | ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - choline | ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - choline | Sclérose en plaques récurrente (SEP-R) MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: UVEDOSE 100 000 UI, solution buvable en ampoule Product Name: UVEDOSE 100 000 UI INN or Proposed INN: COLECALCIFEROL | MERCK SERONO s.a.s | NULL | Not Recruiting | Female: yes Male: yes | France | ||||
| 13 | NCT01432704 (ClinicalTrials.gov) | March 2008 | 16/8/2011 | Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) | Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS | Multiple Sclerosis | Drug: colecalciferol | University of Turku | Bayer | Completed | 18 Years | 50 Years | Both | 70 | Phase 2/Phase 3 | NULL |
| 14 | NCT01339676 (ClinicalTrials.gov) | March 2008 | 19/4/2011 | Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) | Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS | Multiple Sclerosis | Drug: Colecalciferol;Drug: Placebo capsules | University of Turku | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 70 | Phase 4 | Finland |
| 15 | EUCTR2007-001958-99-FI (EUCTR) | 18/12/2007 | 07/12/2007 | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Patients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Dekristol 20000 IE Product Name: Dekristol INN or Proposed INN: INN COLECALCIFEROL Product Name: Placebo Dekristol SGC 20000 | Merja Soilu Häninen | NULL | Not Recruiting | Female: yes Male: yes | Finland |