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

Tsuda Hiroshi0 个研究点目标入组 640 人开始时间: 2022年12月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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, at Screening.
•-MDS-UPDRS Parts II and III (in OFF state) combined score <= 40 at Screening.
•-Screening genetic test results verifying the absence of a pathogenic LRRK2 variant. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.

•-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.
•-MoCA score < 24 at the Screening Visit.

发起方

Tsuda Hiroshi