EUCTR2018-002722-22-NL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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 diagnostic criteria
- •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
- •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 portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
- •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 halflives
- •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 upper 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 interpre-tation 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
研究者
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