JPRN-UMIN000023854招募中未知
Efficacy Study of Repeated Doses of L-arginine in Patients with HTLV-1 Associated Myelopathy - Efficacy Study of Repeated Doses of L-arginine in Patients with HTLV-1 Associated Myelopathy
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(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
研究者
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