Chronic fatigue syndrome/Myalgic encephalomyelitis
Conditions
Interventions
Administering the Ibudilast as inhibitors for microglial activation
Sponsors
emoto masanori
Yasuyoshi Watanabe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation 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
| Measure | Time frame |
|---|---|
| Measurement value of PET Performance status Fatigue Questionnaire Scale of problems caused by fatigue CES-D STAI SCL-90-R The Japanese version of the Pittsburgh Sleep Quality Index Questionnaire of health and sleep Cognitive function Activity level Autonomic function Hematologic markers Metabolome Analysis of multiple proteins | — |
Contacts
Public ContactHirohiko Kuratsune
Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University
Outcome results
None listed