NCT03755167暂停2 期
An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting
研究概览
简要总结
This is a prospective, open-label, follow up study to protocol 101/2 - continued treatment by IPL344 IV administered once a day in up to 15 participants with ALS.
The study is designed to determine the safety, tolerability and initial efficacy of IPL344, administered once a day, by IV infusion for up to 36 months
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants ages ≥ 18 to 75 years.
- •Participants that have completed study protocol #101/2
- •A written informed consent signed prior to any study procedure being performed
- •Medically capable to undergo study procedures at the time of study entry
排除标准
- •Participants that did not participate or did not complete 28 treatment days of study protocol #101/
- •Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
- •Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant.
- •Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum pregnancy test from protocol 101/2)
- •Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling or unable to use an effective method of contraception throughout the trial
研究组 & 干预措施
IPL344
Experimental
IV IPL344 administered once a day
干预措施: IPL344 (Drug)
结局指标
主要结局
Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting
时间窗: upto 36 month
All AEs will be recorded, whether considered minor or serious, drug-related or not
次要结局
- Changes from baseline in ALS disease progression(upto 36 months)
研究者
研究点 (2)
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