Part B of the CycloME trial includes patients with severe to very severe CFS/ME.
Based on an analysis of the preliminary response and toxicity data from CycloME, part A, we concluded that in order to extend the trial to include patients with severe to very severe ME, we needed to adjust the protocol and plan the intervention and follow-up of each patient with great care. In order to gain more experience with this highly vulnerable group of patients, we have now received approval from the Regional Ethics’ committee and the Norwegian Medicines Agency to conduct a pilot study involving three to five participants. Any further studies of cyclophosphamide in ME/CFS will depend on the results from part A and part B as well as results from ongoing laboratory studies.
Inclusion for the pilot study is limited to patients who live within a short distance of the established study centres in Bergen and Oslo.