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临床试验/jRCT2031220519
jRCT2031220519进行中（未招募）不适用

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 Japan Ltd.0 个研究点目标入组 640 人开始时间: 2023年5月24日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
640
主要终点
-
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Double Blind

入排标准

年龄范围
30age old over 至 80age old under（—）
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, 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.

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

结局指标

主要结局

-

Time to confirmed worsening in MDS-UPDRS Parts II and III combined score over the treatment period

次要结局

  • Incidence of AEs and SAEs(treatment period)
  • Time to confirmed worsening in MDS-UPDRS Part II score(treatment period)
  • Change in MDS-UPDRS Parts II and III combined score(Baseline to Week 48)
  • Time to confirmed worsening on SE-ADL(treatment period)
  • Change in MDS-UPDRS Parts I, II, and III combined score(Baseline to Week 48)

研究者

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