Italian Real-Life Study on Effectiveness and Safety of New Drugs Including Monoclonal Antibodies, Gepants, Ditans, and Sumatriptan-Naproxen Combination for Preventing and Treating Migraine

What this Trial Is About

Researchers are evaluating the real-world effectiveness, safety, and tolerability of innovative drugs for preventing and treating migraine. These drugs include anti-CGRP monoclonal antibodies, gepants, ditans, and a combination of sumatriptan and naproxen. The study aims to provide data beyond controlled clinical trials to better understand how these treatments work in everyday clinical practice, especially for episodic and chronic migraine as well as medication overuse headache. Participants receive various migraine treatments such as erenumab, fremanezumab, galcanezumab, and eptinezumab anti-CGRP monoclonal antibodies, gepants like atogepant and rimegepant, lasmiditan a ditan, and a sumatriptan-naproxen combination. The study observes the use of these drugs for both preventive and acute migraine treatment in real-life settings. It may also include new migraine drugs authorized during the study period. During the study, participants are monitored at multiple time points from 4 weeks up to 48 weeks after starting treatment. Assessments include tracking the number of migraine days, safety, tolerability, migraine symptoms, disability, medication use, and patient-reported outcomes. The research team evaluates pain freedom at 2 hours after treatment for migraine attacks and monitors the impact on work difficulties and economic resources related to migraine. The total study duration extends up to the end of 2026.

i-NEED: NEw migrainE Drugs Database