EUCTR2018-002722-22-BE进行中（未招募）1 期
Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment 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
- 320
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 at screening visit (month -3) 38
- •2.Disease duration = 18 months at screening visit (month -3)
- •3.Able to perform reproducible pulmonary function tests at screening visit (month -3)
- •4.Forced vital capacity or slow vital capacity =70% of normal at screening visit (month -3)
- •5.Stable on riluzole treatment for 3 months in the lead-in period
- •6.Signed informed consent at screening visit (month -3)
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1.Treatment with edaravone or other unaccepted concomitant therapy (as per section 8)
- •2.Other causes of neuromuscular weakness
- •3.Presence of other neurodegenerative diseases
- •4.Significant cognitive impairment, clinical dementia or psychiatric illness
- •5.Severe cardiac or pulmonary disease
- •6.Other diseases precluding functional assessments
- •7.Other life-threatening diseases
- •8.Any use of non-invasive ventilation (e.g. continuous positive airway pressure, 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
- •9.Gastrointestinal disorder that is likely to impair absorption of study drug from the gastrointestinal tract
- •10.Has taken any investigational study drug within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
- •11.Any clinically significant laboratory abnormality
- •12.Other concurrent investigational medications
- •13.Active peptic ulcer
- •14.Previous surgery or infections of small intestine
- •15.Patients unable to easily swallow the treatment pills
- •16.Acute inflammation of the gallbladder or bile ducts
- •17.Occurrence of frequent biliary colic, biliary infections, severe pancreatic abnormalities
- •18.Bile duct obstruction, calcified X-ray opaque gallstones and reduced mobility of the gallbladder
- •19.Subjects who weigh 88 lbs (40 kg) or less
- •20.Aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- •21.Creatinine clearance 50 ml/min or less
- •22.Any clinically significant neurological, haematological, autoimmune, endocrine, cardiovascular, neo-plastic, renal, gastrointestinal, or other disorder that, in the Investigator's opinion, could in-terfere with the subject's participation in the study, place the subject at increased risk, or con-found interpretation of study results
- •23.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive TUDCA or that the subject is unable or unlikely to comply with the dosing schedule or study evaluations
- •24.The patient of reproductive potential 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)
- •25.The patient is pregnant or breast feeding
研究者
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