UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023854 |
|---|---|
| Receipt number | R000027465 |
| Scientific Title | Efficacy Study of Repeated Doses of L-arginine in Patients with HTLV-1 Associated Myelopathy |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2020/03/13 11:17:50 |
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Basic information
Public title
Efficacy Study of Repeated Doses of L-arginine in Patients with HTLV-1 Associated Myelopathy
Acronym
Efficacy Study of Repeated Doses of L-arginine in Patients with HTLV-1 Associated Myelopathy
Scientific Title
Efficacy Study of Repeated Doses of L-arginine in Patients with HTLV-1 Associated Myelopathy
Scientific Title:Acronym
Efficacy Study of Repeated Doses of L-arginine in Patients with HTLV-1 Associated Myelopathy
Region
| Japan |
Condition
Condition
HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of L-arginine in patients with HTLV-1 associated myelopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Efficacy:
Change in walking speed as measured by 10 meter walk test from Day 0 to Day 7 (time and number of steps)
Key secondary outcomes
- Efficacy:
Change in walking speed as measured by 10 meter walk test from Day 0 to Day 3 and 14 (time and number of steps)
Change in measurements obtained with timed up and go test from Day 0 to Day 3, 7 and 14 (time and number of steps)
Degree of improvement in cell count, protein level and neopterin concentration in spinal fluid
- Safety:
Adverse event (frequency and severity)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients take 0.5g/kg of Argi-U Granule 2-4 times a day for 7 days.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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) Patients diagnosed with HAM/TSP
(2) Patients must have signed an informed consent form at age 20 or older
(3) In patients receiving steroid therapy, a prednisolone-equivalent daily dose of 10 mg or less must be continuously administered for 12 weeks or more without dose modification
(4) Patients who are able to walk at least 10 meters with or without the use of walking aids at the time of signing the patient informed consent
(5) Patients must have voluntarily signed written informed consent to participate in the study
(6) Patients who can and plan to visit the hospital according to the study schedule
Key exclusion criteria
(1) Patients for whom dosage or mode of administration of steroids or other drugs targeting HAM/TSP has been changed within 12 weeks prior to signing the patient informed consent
(2) Patients who have received pulse steroid therapies or doses of interferon within one year prior to signing the patient informed consent
(3) Patients who have participated in interventional studies within 16 weeks prior to signing the patient informed consent
(4) Patients whose result of 10 meters walk test obtained on screening varies by more than 30 percent compared to those obtained within eight weeks prior to signing the patient informed consent, which include any data collected during single or multiple hospital visits
(5) Patients with serious complications such as heart failure, lung diseases, kidney failure, liver failure and uncontrolled diabetes
(6) Patients with cancer or history of cancer
Note, however, that patients with solid tumors which were completely removed and have not recurred within three years prior to signing the patient informed consent may be included. Patients with basal cell cancer of skin, squamous cell cancer (except for malignant melanomas), non-invasive cervical cancer, or cancer in situ of the gastrointestinal tract or corpus uteri, which have been completely cured may also be included even if the patient developed one of those diseases within three years prior to signing the patient informed consent
(7) Patients with ATL
(8) Pregnant or breast-feeding women, women suspected of being pregnant and patients who do not consent to prevent conception by taking appropriate means with the assistance of their partners during the study period
(9) Patients with compressive spinal cord lesions such as osteoarthritis of the spine, ossification of posterior longitudinal ligament, ossification of yellow ligament, which preclude assessment using the walk tests or can worsen the patients symptoms
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takashima |
Organization
Kagoshima University Hospital
Division name
Department of Neurology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima 890-8520, Japan
TEL
099-275-5332
thiroshi@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Matsuura |
Organization
Kagoshima University Hospital
Division name
Department of Neurology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima 890-8520, Japan
TEL
099-275-5332
Homepage URL
pine@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Research on Measures for Intractable Diseases Project of Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Clinical Research Review Board
Address
1-21-24 Korimoto, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-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
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2020 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027465
