CTIS2023-505645-12-00招募中1 期
283PD201 (LUMA): 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
- 1 期
- 状态
- 招募中
- 入组人数
- 523
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 65+（—）
- 性别
- All
入选标准
- •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. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants., Other protocol defined Inclusion criteria may apply. See Protocol section 6.1
排除标准
- •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, Other protocol defined Exclusion criteria may apply. See Protocol section 6.2
研究者
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