NL-OMON55527招募中3 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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
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
- 18 至 99（—）
入选标准
- •1. laboratory-supported, probable, or definite ALS diagnosis, 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
- •All patients who entered and completed the TUDCA-ALS clinical trial can be
- •included in the open-label TUDCA-ALS Extension.
- •1. Completion of the visit M18 (Month 18) of the TUDCA-ALS clinical trial.
- •2. Signed informed consent for participation in the TUDCA-ALS Extension
- •sub-study.
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. At the time of screening, any use of non-invasive ventilation for any
- •portion of the day, or mechanical ventilation via tracheost-omy, 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 at time of enrolment
- •16. Occurrence of frequent biliary colic, biliary infections, severe pancreatic
- •abnormalities
- •17. Subjects who weigh 88 lbs (40 kg) or less at screening
- •18. Sieric Aspartate aminotransferase or alanine aminotransferase
- •concentrations more than 3 times the upper limit of normal
- •19. Creatinine clearance 50 ml/min or less
- •20. 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
- •21. 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 schedule or study evaluations
- •22. The patient is sexually active and is not willing to use highly ef-fective
- •contraception during the study and up to 90 days after the day of last dose
- •1. Treatment with edaravone or other unaccepted concomitant therapy (as per
- •section 8 of the main TUDCA-ALS clinical trial protocol)
- •2. 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
- •3. The patient of reproductive potential is sexually active and is not willing
- •to use highly effective con-traception during the study and up to 90 days after
- •the day of last dose (see Contraceptive Guidance in Appendix A)
- •4. The patient is pregnant or breast feeding
研究者
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