EUCTR2016-001635-12-DE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
- •Male or female subject with age 40 years or greater at the time of signed consent.
- •Meets the following criteria for possible or probable progressive supranuclear palsy (Steele-Richardson-Olszewski Syndrome)
- •- gradually progressive disorder, with age at disease onset greater than or equal to 40 years
- •- either or both of the following two items are met:
- •1. vertical supranuclear gaze palsy
- •2. slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms
- •Presence of PSP symptoms for less than 5 years.
- •Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker).
- •Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).
- •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 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 238
排除标准
- •Subjects who weigh less than 44 kg (97 lbs) at screening.
- •MMSE score less than 15 at screening
- •Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
- •Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period.
- •Evidence of any clinically significant neurological disorder other than PSP
- •The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria.
- •Subject has had a significant illness or infection requiring medical intervention in the past 30 days.
研究者
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