JPRN-jRCT2051220002进行中（未招募）2 期
Phase 1/2 Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS)
Inoue Haruhisa0 个研究点目标入组 25 人开始时间: 2022年4月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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 <= 75age old（—）
- 性别
- All
入选标准
- •1. ALS patients who are categorized as either Definite ALS or Probable ALS in the El Escorial and revised Airlie House criteria for the diagnosis of ALS
- •2. Patients at Grade 1 or 2 in the Japan ALS Severity Scale of the grant-in-aid program for chronic diseases from the Japanese Ministry of Health, Labour and Welfare
- •3. Patients with ALS within 2 years of symptom onset at the time of the first registration
- •4. Patients with change in total ALSFRS-R score during the observation period from -1 to -4 points
- •5. Patients with score of at least 2 on all items of ALSFRS-R; 4.Writing, 5.Feeding behavior 1 must have at least 2 points on each side.
排除标准
- •1. Patients with tracheostomy
- •2. Patients who had decreased respiratory function and complained of dyspnea at the time of enrollment. One of the three items on the ALSFRS-R related to respiratory dyspnea, orthopnea, or respiratory failure is less than 3 points.
- •3. Patients whose percent FVCs are at least 80 percent at the time of first and second registrations
- •4. Patients who have nerve conduction study findings of demyelination such as conduction block
研究者
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