JPRN-UMIN000022050已完成2 期
A Phase II, Randomised, Double-Blind, Placebo-Controlled Study Followed by a Continuing Open Label Study, to Verify the Efficacy and Safty of Intrathecal Administration of KP-100IT using NP022 in Subjects with Amyotrophic Lateral Sclerosis (ALS) - A Phase II, Randomised, Double-Blind, Placebo-Controlled Study Followed by a Continuing Open Label Study, to Verify the Efficacy and Safty of Intrathecal Administration of KP-100IT using NP022 in Subjects with Amyotrophic Lateral Sclerosis (ALS)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
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 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Subjects who - Have serious hepatic disorder, renal disorder, cardiovascular disease, pulmonary disorder, hematological disorder or metabolism disorder, and are judged by the investigators to be improper for entry in the trial - With HbA1c (NGSP scale) of 6.5% or higher at the check of screening period - Participated in clinical trials of INDs or clinical studies receiving treatment within a month before interim registration (30 days including interim registration date) - With the following diseases or symptoms which might affect safety: malignant tumor, intrathecal infection, intrathecal tumor, proliferative retinopathy, depressed respiratory function (less than 70 of %FVC) - Have a medical history of cancer - Have a drug allergy - Newly started taking of Riluzole after obtaining IC - Participated in the Phase I Trial (protocol KP-100-ND001) - With allergy to antibiotics or intolerance for devices implantation - With allergy to the material of NP022, and including suspected above - Have an anatomical difficulty in intrathecal catheterization - Have an abnormality other than ALS in the spinal cord, the spine, the subarachnoidal cavity, or cerebrospinal fluid circulation, and are judged to be inappropriate for this trial - With infectious diseases requiring a systemic therapy, meningitis, sepsis, bacteremia, peritonitis, or cutaneous infection, and including suspected above - With bleeding diathesis - With impaired coagulation-fibrinolysis, or taking anticoagulant or antiplatelet drugs - Diagnosed as dementia - Mentally impaired or have psychiatric disorders, and are judged to be inappropriate for the trial - Pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods - Judged by the investigators to be inappropriate for any reason
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