HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)
Conditions
Interventions
Patients take 0.5g/kg of Argi-U Granule 2-4 times a day for 7 days.
Sponsors
Kagoshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with HAM/TSP (2) Patients must have signed an informed consent form at age 20 or older (3) In patients receiving steroid therapy, a prednisolone-equivalent daily dose of 10 mg or less must be continuously administered for 12 weeks or more without dose modification (4) Patients who are able to walk at least 10 meters with or without the use of walking aids at the time of signing the patient informed consent (5) Patients must have voluntarily signed written informed consent to participate in the study (6) Patients who can and plan to visit the hospital according to the study schedule
Exclusion criteria
Exclusion criteria: (1) Patients for whom dosage or mode of administration of steroids or other drugs targeting HAM/TSP has been changed within 12 weeks prior to signing the patient informed consent (2) Patients who have received pulse steroid therapies or doses of interferon within one year prior to signing the patient informed consent (3) Patients who have participated in interventional studies within 16 weeks prior to signing the patient informed consent (4) Patients whose result of 10 meters walk test obtained on screening varies by more than 30 percent compared to those obtained within eight weeks prior to signing the patient informed consent, which include any data collected during single or multiple hospital visits (5) Patients with serious complications such as heart failure, lung diseases, kidney failure, liver failure and uncontrolled diabetes (6) Patients with cancer or history of cancer Note, however, that patients with solid tumors which were completely removed and have not recurred within three years prior to signing the patient informed consent may be included. Patients with basal cell cancer of skin, squamous cell cancer (except for malignant melanomas), non-invasive cervical cancer, or cancer in situ of the gastrointestinal tract or corpus uteri, which have been completely cured may also be included even if the patient developed one of those diseases within three years prior to signing the patient informed consent (7) Patients with ATL (8) Pregnant or breast-feeding women, women suspected of being pregnant and patients who do not consent to prevent conception by taking appropriate means with the assistance of their partners during the study period (9) Patients with compressive spinal cord lesions such as osteoarthritis of the spine, ossification of posterior longitudinal ligament, ossification of yellow ligament, which preclude assessment using the walk tests or can worsen the patients symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Efficacy: Change in walking speed as measured by 10 meter walk test from Day 0 to Day 7 (time and number of steps) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Efficacy: Change in walking speed as measured by 10 meter walk test from Day 0 to Day 3 and 14 (time and number of steps) Change in measurements obtained with timed up and go test from Day 0 to Day 3, 7 and 14 (time and number of steps) Degree of improvement in cell count, protein level and neopterin concentration in spinal fluid - Safety: Adverse event (frequency and severity) | — |
Countries
Japan
Contacts
Public ContactEiji Matsuura
Kagoshima University Hospital Department of Neurology
Outcome results
None listed