Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients
- Conditions
- HTLV-1-associated myelopathy (HAM)
- Registration Number
- JPRN-UMIN000015587
- Lead Sponsor
- ReqMed Company, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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