JPRN-jRCT2021210061进行中（未招募）2 期
Interventional, randomized, double-blind, parallel-group, placebo-controlled study to assess the efficacy, safety and tolerability of Lu AF82422 in patients with Multiple System Atrophy
Yazawa Masanari0 个研究点目标入组 60 人开始时间: 2022年1月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- 年龄范围
- >= 40age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •The participant is diagnosed with possible or probable MSA of the multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C) sub-type at the Screening Visit.
- •-The participant had onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms within 5 years prior to the Screening Visit in the judgement of the investigator.
- •-The participant has an UMSARS Part I score <=16 (omitting question 11 on sexual function) at the Screening Visit.
- •-The participant has a cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score >=22 at the Screening Visit.
排除标准
- •-The participant has been treated with an anti-alpha-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of alpha-synuclein aggregation within the last 12 months.
- •-The participant has any past or current treatment with an active vaccine targeting alpha-synuclein.
- •-The participant has 2 or more blood relatives with a history of MSA.
- •-The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease).
- •-The participant has a current diagnosis of movement disorders that could mimic MSA (for example, Parkinson disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism), per investigator discretion.
研究者
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