Clinical Research Directory

Inclusion Criteria: Migraine patients * Adults between 25 and 55 years of age of both sexes; * Patients diagnosed with high-frequency migraine (HFM) 8 or more migraine days/month) or CM with or without aura (\>15 headache days migraine/month, of which 8 have migraine characteristics) according to the International Classification of Headache Disorders, 3rd edition, (ICHD-3); * Females had to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control. Healthy controls * Adults between 25 and 55 years of age of both sex; * Absence of any past, or first-degree familial history of recurrent primary or secondary headache disorders. Exclusion Criteria: For the clinical population: * Headache on more than 25 days/month in the last 3 months; * Medication overuse according to the ICHD-3 criteria. For the entire study population (migraine and healthy controls) * Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease); * Evidence of drug, smoking or alcohol abuse or dependence within 12 months prior to V1, based on medical records or patient self-report. An alcohol consumption \>100g/week will be considered as an abuse; * Pregnant or breastfeeding women; * Women of childbearing potential, defined as all women physiologically capable of becoming pregnant who are not on contraception; * Concomitant use of other migraine preventive drugs that may interfere with the endpoints of the study.