Safetyness and mechanisms of action of inhibitor for microglia activation on the patients with neuroinflammation evidenced by PET.

JRCT ID: jRCTs051190067

Registered date:23/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic fatigue syndrome/Myalgic encephalomyelitis
• Date of first enrollment: 23/10/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Administering the Ibudilast as inhibitors for microglial activation

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 59age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: emoto masanori
• Secondary Sponsor: Yasuyoshi Watanabe
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Astellas Pharma Inc.