JPRN-jRCT2051190001招募中1 期
Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS)
Inoue Haruhisa0 个研究点目标入组 24 人开始时间: 2019年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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 至 79age（—）
- 性别
- All
入选标准
- •1. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. To be additionally signed by a delegate signer if the subject is unable to handwrite.
- •2. Patients with positive already-reported SOD1 gene mutation and progressive muscle weakness; sporadic ALS patients who are categorized as either 'Definite ALS' or 'Probable ALS' or 'Probable-laboratory supported ALS' in the Updated Awaji Criteria for the diagnosis of ALS
- •3. 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; patients with positive SOD1 mutation of Grade 1, 2 or 3
- •4. Patients with ALS that occurred within 2 years at the time of the first registration; patients with positive SOD1 mutation within 5 years after disease onset
- •5. Patients who can visit hospital regularly as outpatients
- •6. Patients with change in total ALSFRS-R score during the observation period are -1 to -3 points
- •7. Urine pregnancy test (for females of childbearing potential) negative at screening
- •8. Patients with appropriate renal function at the time of the first and second registrations
- •9. Patients with appropriate hepatic function at the time of the first and second registrations
- •10. Able to take oral tablets
排除标准
- •1. Patients with tracheostomy
- •2. Patients who have used non-invasive ventilation due to ALS symptoms
- •3. Patients whose %FVCs are less than 70% at the time of first and second registrations
- •4. Patients who have nerve conduction study findings of demyelination such as conduction block
- •5. Patients who are taking edaravone; patients who started riluzole or edaravone after start of the observation period; patients who changed the dosage of riluzole after start of the observation period
- •6. Patients with bulbar type ALS with dysphagia and dysarthria
- •7. Patients with cognitive impairment
- •8. Pregnant female patients; breastfeeding female patients; fertile male and female patients of childbearing potential who are unwilling or unable to use 1 highly effective methods for the duration of the study and for at least 28 days after the last dose of investigational product
- •9. History of clinically significant or uncontrolled cardiac disease including
- •10. Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval
- •11. History of malignancy within 5 years prior to registration
- •12. Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
- •13. Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- •14. Recent or ongoing clinically significant GI disorder
- •15. Patients with chronic obstructive pulmonary disease
研究者
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