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 2015/12/29 18:11:37

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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 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


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

Value
https://center6.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