跳至主要内容
临床试验/EUCTR2016-002554-21-IT
EUCTR2016-002554-21-IT进行中(未招募)1 期

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy - A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and s

BIOGEN IDEC RESEARCH LIMITED0 个研究点目标入组 490 人开始时间: 2021年5月25日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
490

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -Participants with probable or possible PSP
  • -Able to ambulate independently or with assistance
  • -Able to tolerate MRI
  • -Have reliable caregiver to accompany participant to all study visits
  • -Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at
  • -Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned
  • 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 138
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 321

排除标准

  • -Presence of other significant neurological or psychiatric disorders
  • -Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neauron disease
  • -History of early, prominent rapid eye movement (REM) sleep behaviour disorder
  • -History of or screening brain MRI scan indicative of significant abnormality
  • -Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay

研究者

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