HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)
Conditions
Interventions
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 graduall
Sponsors
St. Marianna University School of Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The patient who has diagnosed with HAM based on the Belem criterion. (2) The patient over 18 years of age at the day of giving informed consent. (3) The patient who can walk more than 10 meters regardless of the necessity of walking aids at the day of giving informed consent. However, the use of the walk aid is allowed it less than two sticks. The use of the walker is possible. (4) The patient that the main organ function is maintained. (To confirm by the most recent inspection data within 28 days of enrollment.) 1. Neutrophils: more than 1500/mm3 2. PLT: more than 100,000/mm3 3. Hb : more than 9.0 g/dL 4. AST: within 3 times of the upper limit of the institution criteria 5. ALT: within 3 times of the upper limit of the institution criteria 6. Serum Cre: within 3 times of the upper limit of the institution criteria 7. HbA1c: within 6.5 percent (5) The patient or the legally acceptable representative gives of his/her own free will consent to participate this study. (6) The patient that can come to the hospital for a treatment and a follow-up along the schedule of study.
Exclusion criteria
Exclusion criteria: (1)Patients who have received corticosteroids or other treatment targeted to HAM within 12 weeks prior to giving informed consent (3)Patients who have undergone invasive surgeries requiring general anesthesia within 24 weeks prior to giving informed consent (4)Patients who have participated in other treatment studies within 16 weeks prior to giving informed consent (5)Patients who have undergone live or attenuated/inactivated vaccinations within four weeks of giving informed consent, or who plan to be vaccinated during the course of the study. (6)Patients taking the ascorbic acid more than 1.5g/day, prosultiamine, or pentosan polysulfate within two weeks of giving informed consent. (7)Patients with a history of acute myocardial infarction (8)Patients with a history of tuberculosis or with active tuberculosis (9)Patients with serious complicating conditions (10)Patients with uncontrolled hypertension (11)Patients with uncontrolled electrolyte imbalance (12)Patients with thrombosis (13)Patients with a history of cancer with complications (14)Patients with peptic ulcer (15)Patients with ATL (16)Patients with poorly controlled eye disease (17)Patients with a history of steroid-induced glaucoma (18)Pregnant or breastfeeding women or patients who may become pregnant or withhold assent to prevention of conception by taking appropriate approach such as condom in cooperation with their partners during the study period (19)Patients in whom assessment with the walk test is difficult or the symptoms can be worsened by the walk test (20)Patients with neurological deficits or findings on MRI suggesting it due to disorders other than HAM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy:Presence or absence of 30% or more improvement in a walking time of 10-meter walk test or one grade or more improvement in OMDS at 15 days compared with baseline level. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: -A walking time of 10-meter walk test. 1. Presence or absence of 30% or more improvement in a walking time of 10-meter walk test. 2. An area under the curve from at 15 days and 29 days (4 weeks) compared with baseline level. 3. A variation at 15 days and 29 days (4 weeks) compared with baseline level. -A walking distance for 2 or 6 minutes. 1. An area under the curve from at 15 days and 29 days (4 weeks) compared with baseline level. 2. A variation at 15 days and 29 days (4 weeks) compared with baseline level. -OMDS. Presence or absence of one grade or more improvement in OMDS at 15 days compared with baseline level. -A neopterin concentration in cerebrospinal fluid. A variation at 15 days compared with baseline -A ratio of subjects treated the Methylprednisolone pulse therapy from 29 days (4weeks) to 169 days (24 weeks). | — |
Countries
Japan
Contacts
Public ContactUshitani,Kuwahara
HAMLET-P Coordinating Center Clinical Research Data Center,St. Marianna University School of Medicine
Outcome results
None listed