A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease

Biogen Idec Research Limited0 个研究点目标入组 640 人开始时间: 2022年6月27日最近更新: 2024年2月19日

研究概览

暂无简介。

•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. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.
•NOTE: Other protocol defined Inclusion criteria may apply. See Protocol section 6.1
•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 550
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•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 6.2

发起方