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 | EUCTR2009-013884-21-PL (EUCTR) | 20/05/2010 | 13/01/2010 | 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) | 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 BV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Germany;Belgium;Poland | |||
| 2 | NCT01039103 (ClinicalTrials.gov) | December 2009 | 20/12/2009 | Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS) | 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) | Acute Exacerbation of Remitting Relapsing Multiple Sclerosis;Clinically Isolated Syndrome | Drug: PEG-liposomal prednisolone sodium phosphate;Drug: Methylprednisolone | Galapagos NV | NULL | Terminated | 18 Years | 65 Years | Both | 15 | Phase 2 | Belgium;Germany;Poland |
| 3 | EUCTR2009-013884-21-DE (EUCTR) | 18/11/2009 | 09/09/2009 | 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) | 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 BV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Poland;Belgium;Germany | |||
| 4 | EUCTR2009-013884-21-BE (EUCTR) | 13/11/2009 | 10/09/2009 | 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) | 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 BV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Poland;Belgium;Germany |