NCT02606630终止1 期
A [C-11]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT-555 on Central Nervous System Inflammation in Subjects With Relapsing Forms of Multiple Sclerosis
AbbVie2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in translocator protein expression
研究概览
简要总结
This open-label positron emission tomography (PET) study is designed to determine the effect of ABT-555 on translocator protein expression level in participants with relapsing forms of multiple sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of relapsing-remitting MS (RRMS) or relapsing secondary progressive MS (SPMS)
- •Neurologically stable at Screening, in the investigator's judgment and not actively experiencing or recovering from a recent relapse in the 30 days preceding the Screening Visit
- •A Kurtzke Expanded Disability Status Scale (EDSS) score of 1.0 to 6.0, inclusive at the Screening Visit
- •High or mixed affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at screening
排除标准
- •Diagnosis of primary progressive or non-relapsing secondary progressive MS
- •Smoking more than 10 cigarettes per day or use of a nicotine patch
- •Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
- •Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
- •Any type of live virus vaccine from 4 weeks before randomization
- •History of abnormal laboratory results
研究组 & 干预措施
ABT-555
Experimental
ABT-555 will be administered at Visit 4 for Part 2 only
干预措施: ABT-555 (Drug)
结局指标
主要结局
Change in translocator protein expression
时间窗: Day 0 and 109 days
Compare 2 dynamic positron emission tomography scans to examine the effect of a single administration of ABT-555 on translocator protein expression
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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