METHYLPREDNISOLONE SODIUM SUCCINATE ( DrugBank: Methylprednisolone )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎6
49全身性エリテマトーデス1
50皮膚筋炎/多発性筋炎1
51全身性強皮症2
211左心低形成症候群1

13. 多発性硬化症/視神経脊髄炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000620-34-DE
(EUCTR)
06/05/202008/11/2019Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
INN or Proposed INN: IMATINIB MESILATE
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Department of Clinical Neuroscience, Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Germany;Sweden
2EUCTR2018-000620-34-SE
(EUCTR)
24/04/201814/03/2018Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
INN or Proposed INN: IMATINIB MESILATE
Trade Name: Solu-Medrol
Product Name: Solu-Medrol
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Department of Clinical Neuroscience, Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Sweden
3EUCTR2009-013884-21-PL
(EUCTR)
20/05/201013/01/2010A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.1;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: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Germany;Belgium;Poland
4EUCTR2009-013884-21-DE
(EUCTR)
18/11/200909/09/2009A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
MedDRA version: 14.0;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: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Poland;Belgium;Germany
5EUCTR2009-013884-21-BE
(EUCTR)
13/11/200910/09/2009A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome
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: PEG-liposomal Prednisolone Sodium Phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Trade Name: Solu-Medrol
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Enceladus Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Poland;Belgium;Germany
6EUCTR2009-011516-37-DK
(EUCTR)
29/05/200915/05/2009Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMSDouble blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS Multiple Sclerosis, with primary and secondary progressive courses.
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: NeoRecormon
INN or Proposed INN: Solu-Medrol
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Danish Multiple Sclerosis Research CentreNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-003957-28-BE
(EUCTR)
24/10/2006Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE TrialFive year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE Trial Systemic lupus erythematosus nephritisProduct Name: Azathioprine
INN or Proposed INN: Azathioprine
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone sodium succinate
Product Name: Prednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
University Hospital GentNULLNAFemale: yes
Male: yes
216Phase 3Belgium;Denmark;Italy

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-003956-37-BE
(EUCTR)
13/11/200625/10/2006Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM TrialFive year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial Juvenile Dermatomyositis at onsetProduct Name: Prednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone sodium succinate
Product Name: Cyclosporine
INN or Proposed INN: Cyclosporine A
Product Name: Cyclosporine
INN or Proposed INN: Cyclosporine A
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
University Hospital GentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-004613-24-BE
(EUCTR)
17/07/201918/04/2019Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial.Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. - Hit hard and early (very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Solu-Medrol
Product Name: methylprednisolon
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
RadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Belgium;Netherlands
2EUCTR2015-004613-24-NL
(EUCTR)
30/05/201613/04/2016Hit hard and earlyHit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized double-blind placebo-controlled trial. - Hit hard and early (very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: methylprednisolon
INN or Proposed INN: methylprednisolon
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
RadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands

211. 左心低形成症候群


臨床試験数 : 22 薬物数 : 29 - (DrugBank : 9) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 14
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-007413-76-FI
(EUCTR)
27/02/200923/12/2008Metyyliprednisolonin farmakokinetiikka ja -dynamiikka lasten avosydänleikkausten yhteydessäMetyyliprednisolonin farmakokinetiikka ja -dynamiikka lasten avosydänleikkausten yhteydessä Lasten ja nuorten sairaalassa (HUS) hoidettavat 1-12 kk ikäiset avosydänleikkaukseen tulevat potilaat, joilla on sydänvikanan TOF, AVSD tai VSD.Lasten ja nuorten sairaalassa (HUS) hoidettavat korkeintaan 28 päivän ikäiset avosydänleikkaukseen tulevat potilaat, joilla on sydänvikana TGA, HLHS tai IAA.
MedDRA version: 9.1;Level: LLT;Classification code 10010495;Term: Congenital heart disease NOS
Trade Name: Solu-Medrol
INN or Proposed INN: metyyliprednisoloninatriumsuksinaatti
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Pertti SuominenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Finland