EUCTR2018-002722-22-IT进行中（未招募）1 期
Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS
IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 440 人开始时间: 2021年1月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Probable laboratory-supported, probable, or definite ALS, as defined by El Escorial Revised ALS diag-nostic criteria 38
- •2. Disease duration = 18 months
- •3. No swallowing difficulty (4 at ALSFRS-R swallowing subscore)
- •4. Able to perform reproducible pulmonary function tests
- •5. Forced vital capacity =70% of normal
- •6. Stable on riluzole treatment for 3 months in the lead-in period
- •7. Signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •8. Treatment with edaravone or other unaccepted concomitant therapy (as per Section 8)
- •9. Other causes of neuromuscular weakness
- •10. Presence of other neurodegenerative diseases
- •11. Significant cognitive impairment, clinical dementia or psychiatric illness
- •12. Severe cardiac or pulmonary disease
- •13. Other diseases precluding functional assessments
- •14. Other life-threatening diseases
- •15. At the time of screening, any use of non-invasive ventilation (e.g. continuous positive airway pres-sure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation) for any por-tion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementa-tion
- •16. Gastrointestinal disorder that is likely to impair absorption of study drug from the gastrointestinal tract
- •17. Has taken any investigational study drug within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
- •18. Any clinically significant laboratory abnormality
- •19. Other concurrent investigational medications
- •20. Active peptic ulcer
- •21. Previous surgery or infections of small intestine
- •22. Patients unable to easily swallow the treatment pills at time of enrolment
- •23. Occurrence of frequent biliary colic, biliary infections, severe pancreatic abnormalities
- •24. Subjects who weigh 88 lbs (40 kg) or less at screening
- •25. Aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the up-per limit of normal
- •26. Creatinine clearance 50 ml/min or less
- •27. Any clinically significant neurological, haematological, autoimmune, endocrine, cardiovascular, neo-plastic, renal, gastrointestinal, or other disorder that, in the Investigator's opinion, could interfere with the subject's participation in the study, place the subject at increased risk, or confound inter-pretation of study results
- •28. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to re-ceive TUDCA or that the subject is unable or unlikely to comply with the dosing schedule or study evaluations
- •29. The patient is sexually active and is not willing to use highly effective contraception during the study and up to 90 days after the day of last dose (see Contraceptive Guidance in Appendix A).
研究者
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