JPRN-jRCT2061210031已完成2 期
EPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALS - EPIC-ALS
Fujita Koji0 个研究点目标入组 10 人开始时间: 2021年8月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- >= 18age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •(1) subjects providing written informed consent (Subject and representative providing written informed conset are needed, if the subject is under 20 years old.)
- •(2) aged between 18 and 79 years at the time of informed consent
- •(3) meet the revised El Escorial criteria for clinically definite, clinically probable laboratory-supported or clinically probable
- •(4) within 18 months from symptom onset at screening
- •(5) ALSFRS-R total score progression of <-0.3 (>0.3 decline)/month between the onset and screening
- •(If ALSFRS-R at the time of symptom onset is not determined, please set as 48 points)
- •*progression rate is calculated as: (ALSFRS-R at the time of screening - ALSFRS-R at the time of onset)/duration from onset to screening (month).
- •(6) scores of >=2 points on all 12 items of ALSFRS-R
- •(7) scores of 4 points on three items of respiratory subscore of ALSFRS-R
- •(8) scores of >=3 points in ALSFRS-R swallowing item
- •(9) slow vital capacity (SVC) >= 80%
- •(10) on a stable dose of riluzole for at least 30 day prior to registration for pre-observation period
- •(11) ambulant
- •(12) agreement for genetic research
排除标准
- •(1) with a complication or history of significant other medical conditions based on the investigator's judgement
- •(2) complications of psychological disease, cognitive impairment, or Parkinson's disease
- •(3) underwent tracheostomy
- •(4) with experience of using invasive or noninvasive positive pressure ventilation
- •(5) complications or history of drug allergy or severe allergic disease such as anaphylactic shock
- •(6) malignancy within past five years at the time of informed consent
- •(7) contraindications for lumbar puncture at screening
- •(8) contraindications for MRI including Magnetic Resonance Spectroscopy and Difusion Tensor Imaging at screening
- •(9) AST and ALT CK greater than 3 times upper limit of normal at screening
- •(10) CK greater than 2.5 times upper limit of normal at screening
- •(11) eGFR lower than 45 ml/min/1.73m^2 at screening
- •(12) pregnant, nursing, or plan to get pregnant during the course of this clinical trial at screening
- •(13) childbearing potential, or unwilling to use accepted methods of contraception
- •(14) use of edaravone within 30 days from the start of pre-observation period
- •(15) change the dosage or discontinuation of riluzole after informed consent
- •(16) history of administration of EPI-589
- •(17) participation in a clinical trial before informed consent and within 30 days from investigational drug administration (If 5 times of the investigational drug half life is longer than 30 days, it should takes longer times than 5 times of the investigational drug half life) or willingness to participate for other clinical trial at the time of informed consent
- •(18) history of cell therapy or gene therapy before infromed consent
- •(19) ineligible for the clinical trial based on the investigator's judgement
研究者
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