HTLV-1-associated myelopathy (HAM)
Conditions
Interventions
period of intervention: 12 weeks 0-4 weeks: Normal saline solution by subcutaneous injection 4-12 weeks: NaPPS(Pentosan Polysulfate sodium) 50 mg by subcutaneous injection
period of intervention: 12
Sponsors
ReqMed Company, Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) age: 20 years old or older (at the time of the document agreement acquisition) (2) The HAM patient who fulfilled criteria with serum and CSF antiHTLV-I antibody positive (3) The patient who can understand contents in response to the investigational explanation concerned on the occasion of clinical trial participation beforehand, and can give the consent in writing. (4) The patient who can observe antifertility instruction during a clinical trial period.
Exclusion criteria
Exclusion criteria: (1) The person having serious complications (2) The person who received a surgical treatment within six months before clinical trial. (3) The person whose prothrombin time and the activated partial thromboplastin time is out of the inspection standard value range at the time of the screening. (4) The person who has hemorrhagic factor; with a gastric ulcer and a duodenal ulcer and gastrointestinal bleeding doubted. The person with thrombocytopenia. The person who takes anticoagulant, antiplatelet and thrombolytic medications except aspirin. (5) The person who participated in other clinical studies or a clinical trial within four months before agreement acquisition (6) The person who takes vitamin K (7) The person of the keloid constitution (8) The person with past history of drug hypersensitivity or thrombocytopenia (9) The person of alcoholism or drug dependency (10) The person who has possibility of pregnancy. (11) In addition, the person that a\the clinical trial responsibility doctor or the clinical trial allotment doctor judged the participation in this clinical trial to be inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation of the effectiveness 1) Neurologic views (OMDS, spaciticity, clonus, others) 2) Lower limbs exercise usability test (walk test) (10m walk time, six minutes walk distance, two minutes walk distance, Timed improving & Go)) 3) Evaluation of virological study (peripheral blood and CSF HTLV-1 antibody titer) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Evaluation of virological study (peripheral blood HTLV-1 proviral quantity, HTLV-1 proviral quantity in cerebrospinal fluid, and HTLV-1 infected cell count, etc.) 2) Immunologic evaluation (quantity of serum soluble VCAM-1, etc.) 3) Electrophysiological evaluation 4) Urologic clinical evaluation | — |
Countries
Japan
Contacts
Public ContactKatsuya Satoh
Nagasaki University Hospital Clinical research center
Outcome results
None listed