EUCTR2021-003231-29-AT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy - Study of ATH434 in Participants With Multiple System Atrophy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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. Participant is 30 to 75 years old at the time of Screening.
- •2. Participant has clinical features of parkinsonism.
- •3. Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
- •4. Participant has ataxia and/or pyramidal signs on neurological examination.
- •5. Participant is ambulatory.
- •6. Participant has biomarker evidence of MSA in biologic fluid and on MRI
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Participant has motor symptoms for > 4 years.
- •2. Participant has advanced disease, as indicated by frequent falls or choking.
- •3. Participant has evidence of cognitive impairment.
- •4. Participant has structural brain abnormality on MRI.
- •5. Participant has any significant neurological disorder other than MSA.
- •6. Participant has an unstable medical or psychiatric illness.
- •7. Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.
研究者
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