Senior Consultant Øystein Fluge and Professor Olav Mella supervise the ME/CFS research group at the Dept. of Oncology and Medical Physics at Haukeland University Hospital. The coordinator for the clinical trials is study nurse Kari Sørland. The research group consists of doctors and scientists, nurses, research technicians, molecular biologists and health and exercise therapists. The purpose of the research group is the investigation of possible medical treatments for ME/CFS and biological mechanisms involved in the disease.
Clinical trials investigating possible medical treatments for ME/CFS:
RituxME – a national, randomized, double-blind and placebo controlled multicentre phase III study investigating the effect of treatment with the antibody rituximab in patients with ME/CFS.
CycloME part A – a phase II study investigating the effect of treatment with the chemotherapy drug cyclophosphamide in patients with moderate to severe ME/CFS.
CycloME part B – a phase II study investigating the effect of treatment with the chemotherapy drug cyclophosphamide in patients with severe to very severe ME/CFS.
The group also conducts ongoing laboratory experiments based on a biobank containing blood samples and other biological materials donated by the participants in the clinical trials. The purpose of the experiments is to identify disease mechanisms and biomarkers for ME/CFS.
Clinical studies into cell metabolism (at the University of Bergen) and immunology (at Oslo University Hospital) based on the biobank are conducted in collaboration with the research group at Haukeland.
The research has been made possible by generous donations from the Kavli Trust, MEandYou, the Norwegian ME associations and private contributors. The RituxME trial has received grants from the Norwegian Research Council, the Ministry of Health and Care Services and the regional health authorities. Additionally, each study centre makes a significant contribution to the execution of the clinical trials.
Please note that all patients included in the clinical trials must be members of the Norwegian national health care system. However, we hope that the findings and results from our research will ultimately benefit ME patients both in Norway and abroad.
Questions and Answers
Can I apply to take part in a clinical trial?
We have received an overwhelming number of applications for the RituxME and CycloME trials. We are grateful that so many people wish to make a contribution to the ME research, but we have no more openings for participation in the studies. Thus we are unable to accept any further applications.
When will the results of the clinical trials be published?
We aim to publish the results from both the RituxME trial and the CycloME trial, part A, during the first half of 2019.
Can I receive rituximab treatment without participating in a clinical trial?
The purpose of clinical drug trials is to investigate whether the study medications have any relevant effect on symptoms, and whether the toxicity profile is acceptable. In general, no recommendations can be made until the trial results are known.
The overall conclusion of the phase III RituxME trial is that we do not recommend treatment with rituximab for ME/CFS. As the CycloME trial is an open phase II trial, we know that further studies will be required in order to draw any firm conclusions on treatment effect. We do not recommend treatment with cyclophosphamide outside a clinical trial.
Can you provide me with other treatment or diagnose my ME/CFS?
The mandate of the ME/CFS research group at the Dept. of Oncology is strictly limited to research and clinical studies. As a consequence, we are unable to diagnose or treat ME/CFS patients outside of clinical trials. We suggest that you contact your doctor or the relevant department at your local hospital. Alternatively, your local patient association might be able to advise you on the available health care in your country.