2023-505645-12-00招募中2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 311
- 试验地点
- 51
- 主要终点
- Time to confirmed worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period.
研究概览
简要总结
To evaluate the efficacy of BIIB122 225 mg compared with placebo.
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow up period
- 盲法
- Double (Monitor, Carer, Subject, Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Time to confirmed worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period.
Time to confirmed worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period.
次要结局
- Incidence of AEs and SAEs during the treatment period
- Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period
- Change in MDS-UPDRS Parts II and III combined score
- Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period
- Change in MDS-UPDRS Parts I, II, and III combined score
研究者
Clinical Trials Information Desk
Scientific
Biogen Idec Research Limited
研究点 (51)
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