Unique ID issued by UMIN | UMIN000015587 |
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Receipt number | R000018113 |
Scientific Title | Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients |
Date of disclosure of the study information | 2014/11/03 |
Last modified on | 2015/12/29 18:11:37 |
Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients
Clinical trial with NaPPS for HAM patients
Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients
Clinical trial with NaPPS for HAM patients
Japan |
HTLV-1-associated myelopathy (HAM)
Neurology |
Others
NO
We investigate the effectiveness and safety in the subcutaneous administration of NaPPS for HTLV-1 associated myelopathy (HAM) patients.
Safety,Efficacy
Exploratory
Others
Phase II
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)
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
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
4
Treatment
Medicine |
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
20 | years-old | <= |
Not applicable |
Male and Female
(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.
(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
12
1st name | |
Middle name | |
Last name | Hirokazu Shiraishi |
Nagasaki University Hospital
Department of Neurology and Strokology
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
+8195-819-7200
hshiraishi61@hotmail.com
1st name | |
Middle name | |
Last name | Hiroshi Yamamoto |
Nagasaki University Hospital
Clinical research center
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
+8195-819-7256
hiroshiy@nagasaki-u.ac.jp
ReqMed Company, Ltd
ReqMed Company, Ltd
Profit organization
NO
2014 | Year | 11 | Month | 03 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 22 | Day |
2014 | Year | 11 | Month | 04 | Day |
2014 | Year | 11 | Month | 02 | Day |
2015 | Year | 12 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018113
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