Procedures
RS, pain, headache, migraine, NRS
MIGRAINE, ADVERSE EVENTS
During the 24-week treatment phase, patients received erenumab 140 mg or placebo every 4 weeks. The treatment phase comprised a baseline visit and follow-up visits at week 4, 8, 12, 16 and 20. An end of study (EOS) visit was performed at week 24. At baseline visit, patients were randomized and received erenumab or placebo treatment which was continued for the following 12 weeks. At week 12, patients were switched to the other treatment (from erenumab to placebo or vice versa).During screening, patients’ underwent electrocardiogram, neurological examination, physical examination and a detailed clinical history, including prior headache characteristics, average headache and migraine days of the 3 months preceding study entry and prior migraine preventives failure history. From the run-in phase to the end of the study, patients were asked to complete a paper headache diary reporting the monthly migraine days (MMD), migraine attack duration, monthly headache days (MHD), monthly number of days with use of acute treatments (MAT), pain severity according the numerical rating scale (NRS) [At baseline, week 12 and week 24, all participants underwent a brain MRI including RS functional MRI (fMRI), fluid-attenuated inversion recovery, 3D T1-weighted and T2-weighted images, according to a prespecified protocol provided by the central reading facility (Neuroimaging Research Unit, IRCCS San Raffaele Scientific Institute, Milan). The baseline MRI was performed within three days prior to receiving the first dose of study treatment and at week 12 the MRI was performed within three days prior to administration of the fourth dose of treatment in order to explore the effect of 3-month of erenumab. To avoid measuring imaging changes related to acute migraine symptoms, all brain MRI were performed in a migraine/headache-free phase and at least 24 h after the last migraine attack.Vital signs, clinical laboratory parameters and occurrence of adverse events (AE) were investigated during the entire study. All patients who received at least one dose of study treatment were included in the Safety population.