Clinical trial of oral L-Arginine therapy for the patients with HAM/TSP

JRCT ID: jRCTs071180068

Registered date:20/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HTLV-1-associated myelopathy/Tropical spastic paraparesis
• Date of first enrollment: 14/11/2016
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Taking medicine orally

Outcome(s)

• Primary Outcome: Time and Number of Steps for Walking 10 meters on Day7

Secondary Outcome

Time and Number of Steps for Walking 10 meters on Day3,14
Time and Number of Steps for Time Up & Go test on Day3,7,14
Results of Blood test and CSF test

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

HTLV-1 associated myelopathy/Tropical spastic paraparesis:HAM/TSP (Diagnostic criteria according to WHO conference at Kagoshima in 1988)
Inclusion Criteria
Subjects eligible for enrollment in the study must meet all of the following criteria:
(1)Patient with HAM/TSP
(2)Age>=20 years at the time of consent
(3)Ongoing medication for HAM/TSP, with no changes in 12 weeks before enrollment. Subjects on maintenance therapy with steroids must have been receiving <= 10mg/day prednisolone equivalent continuously for at least 12 weeks before enrollment.
(4)Subjects are able to walk >= 10m at screening (use of a single cane, double canes or any walking aid is allowed)
(5)Voluntary written informed consent to participate in the study
(6)Subjects are able to see the Kagoshima University Hospital on the schedule days.

Exclude criteria

Exclusion Criteria
(1)Participation in a clinical trial within 16 weeks before informed consent
(2)10m walking time at screening has changed more than 30% compared with 10m walking time within 8 weeks before consent (data of all the days when visiting multiple days)
(3)Any of the following significant concomitant diseases; Poorly controlled diabetes mellitus
Heart failure
Severe chronic lung disease requiring oxygen therapy
Renal failure
Liver dysfunction
(4)Active malignancy or past history of malignancy (with the exception of resected or surgically cured solid cancer, with no recurrence of the cancer more than 3 years before informed consent, and resected intra-epithelium carcinoma of cervix cancer, uterine body or digestive ducts)
(5)Adult T cell leukemia/lymphoma (ATLL)
(6)Pregnant, breastfeeding or possible pregnant. Subjects without agree to contraception during the study period
(7)Concurrent spinal cord compression lesion (e.g. cervical spine disease, OPLL and OYL) with the exception of conditions that would not affect evaluating 10m walking test in the study, as judged by the investigator)
(8)Concurrent diseases that markedly impair brain function such as psychiatric disorder, epilepsy, dementia, parkinsonism, cerebrovascular disease
(9)Bone fracture within 24 weeks before informed consent
(10)Any other condition unsuitable for participation in the study in the opinion of the investigator

Related Information

• Primary Sponsor: TAKASHIMA HIROSHI
• Secondary ID(s): UMIN000023854