EUCTR2018-002722-22-IE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
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
入排标准
- 性别
- All
入选标准
- •1.laboratory-supported, probable, or definite ALS diagnosis, as defined by El Escorial Revised ALS diagnostic criteria at screen-ing visit (M-3)
- •2.Disease duration = 18 months at screening visit (M-3)
- •3.Able to perform reproducible pulmonary function tests at screening visit (M-3)
- •4.FVC or SVC =70% of normal at screening visit (M-3)
- •5.Stable on riluzole treatment for 3 months in the lead-in period
- •6.Signed informed consent at screening visit (M-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 (substances inhibiting the intestinal absorption of bili-ary acids, antacids containing aluminium hydroxide and/or smectites, estrogens and drugs acting by lowering plasmatic cholesterol; drugs increasing biliary clearance of cholesterol, hepatolesive drugs)
- •2.Other causes of neuromuscular weakness
- •3.Presence of other neurodegenerative diseases
- •4.Significant cognitive impairment, clinical dementia or psychiat-ric 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 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 dos-ing
- •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 re-duced mobility of the gallbladder
- •19.Subjects who weigh 88 lbs (40 kg) or less
- •20.Sieric 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, autoim-mune, endocrine, cardiovascular, neo-plastic, renal, gastroin-testinal, 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 interpretation of study results
- •23.Consideration by the investigator, for any reason, that the sub-ject is an unsuitable candidate to receive TUDCA or that the subject is unable or unlikely to comply with the dosing sched-ule 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
- •25.The patient is pregnant or breast feeding
研究者
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