Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000015587
• Date of registration: 03/11/2014
• Prospective Registration: Yes
• Primary sponsor: ReqMed Company, Ltd
• Public title: Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients
• Scientific title: Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients - Clinical trial with NaPPS for HAM patients
• Date of first enrolment: 2014/11/04
• Target sample size: 12
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018113
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase II

Countries of recruitment

Japan

Contacts

• Name: Hirokazu Shiraishi
• Affiliation: Nagasaki University Hospital Department of Neurology and Strokology

• Name: Hiroshi Yamamoto
• Affiliation: Nagasaki University Hospital Clinical research center

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

HTLV-1-associated myelopathy (HAM)

Intervention(s)

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 weeks 0-4 weeks: Normal saline solution by subcutaneous injection 4-12 weeks: NaPPS(Pentosan Polysulfate sodium) 100 mg by subcutaneous injection
period of intervention: 12 weeks 0-4 weeks: NaPPS 100mg/week by subcutaneous injection 4-12 weeks: NaPPS(Pentosan Polysulfate sodium) 50 mg by subcutaneous injection
period of intervention: 12 weeks 0-4 weeks: NaPPS 100mg/week by subcutaneous injection 4-12 weeks: NaPPS(Pentosan Polysulfate sodium) 100 100 mg by subcutaneous injection

Primary Outcome(s)

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(s)

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

Source(s) of Monetary Support

ReqMed Company, Ltd

Ethics review

Status: YES
Approval date:
Contact: