jRCT2061210070尚未招募不适用
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy (Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Proportion of responders in CASE (Clinical Assessment Scale in Autoimmune Encephalitis)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 15age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients aged 15 years or older at the time of informed consent
- •Patients who meet any of the following (1) to (6):
- •(1) Definite diagnostic criteria for autoimmune limbic encephalitis
- •(2) MRI evidence of demyelination (probable autoimmune encephalitis)
- •(3) Probabilistic diagnostic criteria for anti-NMDAR encephalitis
- •(4) Probabilistic diagnostic criteria for Bickerstaff brainstem encephalitis
- •(5) Probabilistic diagnostic criteria for Hashimoto's encephalopathy
- •(6) Diagnostic Criteria for Autoimmune Encephalitis with Negative but Probable Autoantibodies
- •CASE score of 5 to 22
- •Patients who have had an inadequate response to steroid pulse therapy
排除标准
- •Patients with strongly suspected infectious encephalitis
- •Patients who received immunoglobulin preparations within 8 weeks prior to informed consent
- •Patients who received plasma exchange within 4 weeks prior to informed consent
- •Patients who received immunosuppressants (Rituximab, cyclophosphamide, etc.) within 4 weeks prior to informed consent
- •Patients who have had tumor resection associated with autoimmune encephalitis within 4 weeks prior to informed consent
- •Patients with a history of shock or hypersensitivity to the ingredients of NPB-01
- •Patients with known IgA deficiency
- •Patients with renal disorder
- •Patients with a current or previous history of cerebral or cardiovascular disorders (Asymptomatic cerebral infarction and myocardial infarction that occurred more than 5 years ago are not applicable.)
- •Patients at high risk of thromboembolism
- •Patients with haemolytic/blood loss anaemia
- •Immunosuppressed/immunocompromised patients
- •Patients with decreased cardiac function
- •Pregnant, expected (desired or planned) pregnant, or breastfeeding patients
- •Use of prohibited medications or treatment in this study
- •Patients who received investigational product in this study (re-enrollment prohibited)
- •Patients who have received treatment with investigational product other than this study within 4 months prior to informed consent
- •Patients with a history of hypersensitivity to methylprednisolone sodium succinate
- •Patients who have a tumor associated with autoimmune encephalitis and are considered to require resection during the study period.
- •Patients receiving intravenous general anesthetics or sedative hypnotics
- •Patients in coma
- •Ventilated patients
- •Patients who cannot undergo protocol-specified tests/assessments
- •Other patients considered ineligible for the study by the investigator or subinvestigator
- •Positive herpes simplex virus DNA qualitative test in the screening period.
- •Serum creatinine 2 times or more the upper limit of normal during the screening period.
- •Total protein 9 g/dL or more during the screening period.
- •Patients with hematocrit 55% or more during the screening period
结局指标
主要结局
Proportion of responders in CASE (Clinical Assessment Scale in Autoimmune Encephalitis)
时间窗: 4 weeks
A responder is defined as a patient whose CASE score at Week 4 of the post-treatment follow-up period after treatment with investigational product improved by 40% or more compared to the pre-treatment period.
次要结局
未报告次要终点
研究者
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