From Tom Kindlon on Co-Cure
[This is a translation by Bing Translator. There is a flow chart in Dutch at the site. The original in Dutch is copied below. I don't accept any responsibility with regard to the accuracy of the information (or translation), or with regard to any other matter relating to this drug trial. I just thought people might be interested as there aren't that many drug trials in ME/CFS, particularly in Europe Tom (@TomKindlon)]
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http://www.me-cvs-stichting.nl/?pid=news&id=2240
Participate in drug research
We would like to ask your attention for a medication research that in the short term will start in the Radboud UMC in Nijmegen. For this research is the CiCFS study team looking for women with CVS. In the research of light immune suppression can provide reduction in severe chronic fatigue ...
What is the purpose of the research?
CVS is still a condition for which no obvious cause is found. There is evidence that CFS is caused by an overactive immune system. The aim of this study is to see if suppressing the immune system can reduce your fatigue. This involves Interleukin-1 (IL-1), IL-1 inhibited is a cytokine. Cytokines are part of the immune system.
The immune system
The immune system (immune system) defends the body both against intruders from outside (e.g. bacteria and viruses), as against certain harmful cells already present in our body. Cytokines are proteins and have a boodschapperfunctie between the different cells. There are cytokines that ontstekingsbevorderend work, but there are also
anti-inflammatory cytokines that are active.
Cytokines at CVS
From a scientific research there are indication that people with CFS have a cytokine disturbance in the brain. This is not measurable in the blood. There is, for example, an increase of certain cytokines found in the cerebrospinal fluid (CSF) of people with CFS. Ontstekingsbevorderend is an important cytokine IL-1. IL-1 can be inhibited without creating a risk of serious side effects.
Which medicines are examined?
In the research we compare treatment with placebo with treatment with Anakinra. These medications are injected subcutaneously daily. (Participants are instructed to administer the Center at home.) Anakinra is an anti-inflammatory medication. It inhibits IL-1. It is currently used in patients with for example rheumatism or gout.
Placebo is a medium in which no active substances. Placebos are often used in research. A placebo looks like on the real drug. In this way can be tested or an investigational drug really works.
How is the research carried out?
The research consists of several parts. A screening phase, the treatment phase and a follow-up phase. The examination takes a total of six months. During this period, participants will visit the RadboudUMC three times. At the beginning of the study participants treated with the medicine daily for a month. In the period afterwards,
on multiple moments, blood, saliva, hair, stools, and questionnaires. In the flow chart is showing how the research looks like.
CiCFS Flow Chart
CiCFS Flow Chart
Neighborhood Control
For example, certain values in the blood in a reliable way to be able to compare with persons without fatigue, we ask that people participating in the research once someone of roughly the same age (+/-5 years) and the same sex.
You can take part in?
You have CVS You are a woman You are between the ages of 18 and 59 years old You use, with the exception of paracetamol and birth control, no medications When the above criteria, you may be able to participate in the research.
Are you interested in participating?
If you are interested in participating in the research we kindly ask the CiCFS form. The CiCFS study team are watching if you qualify for participation. It is expected that the first people in May this year. Your application will be sent directly to doctor-researcher M.E. Rafiei, you can sign up here.
