NL-OMON51537尚未招募2 期
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson*s Disease - 283PD201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Biogen
- 入组人数
- 13
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
- 18 至 99（—）
入选标准
- •Key Inclusion Criteria:
- •Clinical diagnosis of PD meeting the Movement Disorder Society Clinical
- •Diagnostic Criteria within 2 years of the screening visit, inclusive, and at
- •least 30 years of age at the time of diagnosis
- •Modified Hoehn and Yahr scale, stages 1 to 2 (in OFF state), inclusive
- •MDS-UPDRS Parts II and III (in OFF state) combined score less than or equal
- •to (<=)40 at screening
- •Screening genetic test results verifying the absence of a pathogenic
- •leucine-rich repeat kinase 2 (LRRK2) variant (i.e., G2019S, N1437H, R1441G,
- •R1441C, R1441H, Y1699C, or I2020T). Participants with additional LRRK2 variants
- •may be excluded if data emerge to convincingly support an association of the
- •variants with LRRK2-PD pathogenicity.
- •NOTE: Other protocol defined Inclusion criteria may apply. See Protocol section
排除标准
- •Key Exclusion Criteria:
- •Clinically significant neurological disorder other than PD, including but not
- •limited to stroke, dementia, or seizure, within 5 years of screening visit, in
- •the opinion of the Investigator
- •Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or
- •progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
- •Montreal Cognitive Assessment (MoCA) score <24 at the screening visit
- •NOTE: Other protocol defined Exclusion criteria may apply. See Protocol section
研究者
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