UMIN-CTR Clinical Trial

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
Email	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
Email	pine@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027465