26. HTLV-1関連脊髄症 HTLV-1-associated myelopathy Clinical trials / Disease details
臨床試験数 : 29 / 薬物数 : 47 - (DrugBank : 29) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 119
| 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 | JPRN-UMIN000024086 | 2016/09/16 | 20/09/2016 | Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor) | Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor) - HAMLET-P | HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP) | Drugs which possibly affect assessment in the study (e.g. methylprednisolone, prednisolone and other agents targeted to HAM) will be forbidden or limited until Week 48 and periodic evaluation and tests will be performed. | St. Marianna University School of Medicine Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 5 | Phase 2 | Japan |
| 2 | JPRN-UMIN000024085 | 2016/09/16 | 20/09/2016 | Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor) | Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor) - HAMLET-P | HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP) | Prednisolone is orally administered at a maximum dose of 0.5mg/kg/day and then tapered to a maintenance dose of 5mg/day. Indistinguishable placebo is orally administered for 24 weeks, and then 5mg/day of prednisolone for the next 24 weeks. | St. Marianna University School of Medicine Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 40 | Phase 2,3 | Japan |
| 3 | JPRN-UMIN000023798 | 2016/08/31 | 31/08/2016 | Phase IIb clinical trial of steroid therapy in patients with HAM | Phase IIb clinical trial of steroid therapy in patients with HAM - HAMLET-P | HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP) | Following to administrate Methylprednisolone 1000mg/day intravenously slowly for consecutive three days, Prednisolone is administered orally for a maximum dose in 0.5mg/kg/day, then decreased gradually and terminated. There is a case to maintain the dose of Prednisolone by the degree of a progress of underlying disease. Prednisolone is administered orally for a maximum dose in 0.5mg/kg/day, then decreased gradually and terminated. There is a case to maintain the dose of Prednisolone by the degree of a progress of underlying disease. | St. Marianna University School of Medicine Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 8 | Phase 2,3 | Japan |