A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine

Prior treatment

• Diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction;
• Diagnosis of secondary headache types, except medication overuse headache, which is permitted;
• Currently taking \> 1 prescribed drug for the preventive treatment of migraine;
• Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment less than 5 months prior to screening.

Other

• Diagnosis of chronic migraine;
• Diagnosis of other primary headache types, except tension-type headache, which is permitted;

• Participant has a diagnosis of EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches;
• Participant age \< 50 years at the time of migraine onset;
• Participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and
• During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary.