NCT05109091已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 23
- 主要终点
- Change in iron content as measured by brain MRI
研究概览
简要总结
This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has clinical features of parkinsonism.
- •Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
- •Participant has ataxia and/or pyramidal signs on neurological examination.
- •Participant is ambulatory.
- •Participant has biomarker evidence of MSA in biologic fluid and on MRI.
排除标准
- •Participant has motor symptoms for > 4 years.
- •Participant has advanced disease, as indicated by frequent falls or choking.
- •Participant has structural brain abnormality on MRI.
- •Participant has any significant neurological disorder other than MSA.
- •Participant has an unstable medical or psychiatric illness.
- •Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.
研究组 & 干预措施
ATH434 Arm 1
Experimental
干预措施: ATH434 dose level 1 (Drug)
ATH434 Arm 2
Experimental
干预措施: ATH434 dose level 2 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in iron content as measured by brain MRI
时间窗: Change from Baseline to Week 52
次要结局
- Change in Neurofilament Light Chain Levels(Change from Baseline to Week 52)
- Change in SF-36 Score(Change from Baseline to Week 52)
- Change in Unified MSA Rating Scale (UMSARS) Score(Change from Baseline to Week 52)
研究者
研究点 (23)
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