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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015587
Receipt No. 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

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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
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
Middle name
Last name Hirokazu Shiraishi
Organization Nagasaki University Hospital
Division name Department of Neurology and Strokology
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL +8195-819-7200
Email hshiraishi61@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Yamamoto
Organization Nagasaki University Hospital
Division name Clinical research center
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL +8195-819-7256
Homepage URL
Email hiroshiy@nagasaki-u.ac.jp

Sponsor
Institute ReqMed Company, Ltd
Institute
Department

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
Address
Tel
Email

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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Anticipated trial start date
2014 Year 11 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 02 Day
Last modified on
2015 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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