JPRN-jRCTs051190067已完成未知
Safetyness and mechanisms of action of inhibitor for microglia activation on the patients with neuroinflammation evidenced by PET.
emoto masanori0 个研究点目标入组 13 人开始时间: 2019年10月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 13
研究概览
简要总结
euroinflammation in two patients who improved dramatically by Ibudilast treatment was significantly lowered. Clinical scores, total fatigue scores, number of snooze, power of autonomic nerve function were improved and lactate in the plasma was decreased in 11 patients. When we could increase the number of the participants, we might have statistically significant results with neuroinflammation observed by PET, too.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 59age old（—）
- 性别
- All
入选标准
- •1) 20 to 60 years old at the time of informed consent, Male and Female
- •2) Meet the diagnosis both CDC criteria (1994) and ME/CFS (2003)
- •3)Patients with brain positive inflammation dected by positron emission tomography (PET), [F18]DPA-714. Patients of brain positive inflammation are defined by 2.0SD higher than healthy control's average by the research of [Efficacy of inhibitors for microglial activation in the patients with neuroinflammation evidenced by PET(AMED:17ak0101059h0002)].
- •4) Patients who have fatigue performance status 3 to 9
- •5) Patients who have provided written informed consent.
排除标准
- •1) Pregnant women, those who are likely to become pregnant, those who are breastfeeding
- •2) Patients who have metal, pacemaker in the body by surgery etc.
- •3) Claudophobia
- •4) Persons who are experiencing psychiatric diseases before suffering chronic fatigue syndrome
- •5) Patients who have clinically significant symptoms (cancer, cardiovascular disease, liver or kidney disease, immunodeficiency, past mental disease history etc)
- •6) Patients who have a history of substance abuse (alcohol or drug) or drug addiction within 12 months before this study registration
- •7) Patients who the doctor judged clinically significant abnormality in clinical examination value
- •8) From three months earlier administering experimental drug to the end of trial , persons who are unable to stop taking drug which may affect microglial activation , antibiotics or Chinese medicine with anti-inflammatory effects.
- •9) BMI less than 15, more than 30
- •10)Person who have a history of hypersensitivity to ingredients of Ibudilast
- •11)Others who judged inappropriate by the attending physician
研究者
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