Study design
headache/migraine, headaches, headache, migraine, Migraine
MIGRAINE, MIGRAINE
SUNLIGHT was a randomized, double-blind, parallel-group, placebo-controlled phase 3 clinical trial that enrolled patients with a dual diagnosis of migraine and MOH for the purpose of evaluating the efficacy of eptinezumab within this specific demographic. This multicenter study was conducted in accordance with Good Clinical Practice standards as defined by the International Conference on Harmonisation and all applicable federal and local regulations. Each study site’s local review board or alternatively a central institutional review board/ethics committee approved all study documents. Patients were recruited from specialist settings in Mainland China, Republic of Korea, Taiwan, Spain, and Georgia. All patients provided written informed consent prior to their participation in the study. To view this registered study, see ClinicalTrials.gov under the following identifier: NCT04772742 (26/02/2021).In this 36-week study, patients were followed through a screening period (28–30 days), a placebo-controlled period measuring efficacy (12 weeks), and an open-label period measuring safety and tolerability (12 weeks). For patients entering the open-label period, safety was followed for 20 weeks (12 weeks during the open-label period and 8 weeks during the safety follow-up period). These 20 weeks of safety data were analyzed and presented together. For patients not entering the open-label period, 20 weeks of safety follow-up data counted from when they received the first study drug infusion. The safety data collected up to Week 12 are thus included in the tabulations of the placebo-controlled period safety data, whereas the data collected at the safety follow-up visit for these patients are reported separately in data listings (Supplemental Figure Patients were assigned an electronic headache diary, called an eDiary, at the screening visit and were required to complete daily entries from the screening visit to the primary outcome visit (Week 12) or until the withdrawal visit. Patients used the eDiary in their local language to record information regarding any experienced headaches, such as start time, stop time, headache severity, additional symptoms, and acute headache/migraine medication use. The yes/no responses to headache items and the severity rankings (mild, moderate, or severe) helped investigators track any effects of treatment. Migraine was ranked as either moderate or severe. Information collected from the eDiary was used to derive headache/migraine study endpoints.