Safetyness and mechanisms of action of inhibitor for microglia activation on the patients with neuroinflammation evidenced by PET.
- Conditions
- Chronic fatigue syndrome/Myalgic encephalomyelitis
- Registration Number
- JPRN-jRCTs051190067
- Lead Sponsor
- emoto masanori
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 13
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation<br> Adverse events that the relevance to the study drug can not be denied and adverse events that can be denied the relevance are summarized the number of incidence and rate.
- Secondary Outcome Measures
Name Time Method Measurement value of PET<br>Performance status<br>Fatigue Questionnaire<br>Scale of problems caused by fatigue<br>CES-D<br>STAI<br>SCL-90-R<br>The Japanese version of the Pittsburgh Sleep Quality Index<br>Questionnaire of health and sleep<br>Cognitive function<br>Activity level<br>Autonomic function<br>Hematologic markers<br>Metabolome<br>Analysis of multiple proteins