UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015587 |
|---|---|
| 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 | 2024/05/05 15:49:13 |
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Basic information
Public title
Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients
Acronym
Clinical trial with NaPPS for HAM patients
Scientific Title
Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients
Scientific Title:Acronym
Clinical trial with NaPPS for HAM patients
Region
| Japan |
Condition
Condition
HTLV-1-associated myelopathy (HAM)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effectiveness and safety in the subcutaneous administration of NaPPS for HTLV-1 associated myelopathy (HAM) patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
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)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
Interventions/Control_2
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
Interventions/Control_3
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
Interventions/Control_4
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
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Shiraishi |
Organization
Nagasaki University Hospital
Division name
Department of Neurology and Strokology
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL
+8195-819-7200
hshiraishi61@hotmail.com
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Satoh |
Organization
Nagasaki University Hospital
Division name
Clinical research center
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL
09049918364
Homepage URL
satoh-prion@nagasaki-u.ac.jp
Sponsor or person
Institute
ReqMed Company, Ltd
Institute
Department
Personal name
Funding Source
Organization
ReqMed Company, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
Tel
095-819-7000
satoh-prion@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s13365-014-0244-8
Number of participants that the trial has enrolled
12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018113
