EUCTR2016-003622-16-FI进行中(未招募)1 期
Targeting SPMS: Effect of teriflunomide treatment on microglial activation in an MS patient cohort at risk of progression. A [11C]PK11195 Brain PET study.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
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
- •-Signing the consent form
- •-Having used teriflunomide treatment for at least 6 months
- •-40-55 years of age at the time of signing the research consent form
- •-MS diagnosis in accordance with either the Poser or McDonald criteria
- •-EDSS 2-6.5
- •-Clear lesion load in brain MRI (>9 T2 lesions)
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients suffering from another brain disease in addition to MS
- •-Significant pathology in the MRI scan other than MS-related pathology
- •-Steroid treatment within 4 weeks prior to the scan
- •-Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
- •-Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study
- •-Severe hepatic impairment
- •-Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l.
研究者
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