NCT05753852招募中3 期
Open Label Extension Study to Investigate Long Term Safety, Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the TUDCA-ALS Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 23
- 主要终点
- Long-term safety and tolerability of TUDCA during the open-label phase
研究概览
简要总结
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.
详细描述
The TUDCA-ALS Open label extension study is designed to investigate long term safety, tolerability and efficacy of tauroursodeoxycholic acid in patients with ALS who completed the TUDCA-ALS study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the visit M18 (Month 18) of the TUDCA-ALS clinical trial.
- •Signed informed consent for participation in the TUDCA-ALS Extension sub-study
排除标准
- •Treatment with edaravone or other unaccepted concomitant therapy
- •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
- •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
- •The patient is pregnant or breast feeding
研究组 & 干预措施
Active treatment
Experimental
干预措施: Tauroursodeoxycholic Acid (Drug)
结局指标
主要结局
Long-term safety and tolerability of TUDCA during the open-label phase
时间窗: 18 months
Long-term safety and tolerability assessed through adverse reaction, concomitant treatment, and routine biochemistry analyses
次要结局
- Survival time(18 months)
- Change in disease progression and functional impairment(18 months)
研究者
研究点 (23)
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