JPRN-jRCTs071180068招募中1 期
An open-label, single center, non-randomized, Phase 1 study to evaluate safety and efficacy of oral medication with L-Arginine for the patients with HAM/TSP
TAKASHIMA HIROSHI0 个研究点目标入组 20 人开始时间: 2019年3月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
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