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. If the pilot patients tolerate the treatment well, we may include a total of up to 20 participants. In the original protocol we aimed for a collaboration with the patient's local primary health service, in order to complete treatment and follow-up at local hospitals or nursing homes. This plan was not approved, and therefore inclusion for the pilot study will be limited to patients who live within a short distance of the established study centres in Bergen and Oslo. Possible candidates for participation in the pilot study are contacted directly.