Italian Real-life Multicenter Observational Study on Efficacy, Tolerability, and Safety of New Drugs for Preventive or Acute Migraine Treatment

What this Trial Is About

Researchers are studying the real-world effectiveness, safety, and tolerability of new migraine treatments including anti-CGRP monoclonal antibodies, gepants, ditans, and a combination of sumatriptan and naproxen. These treatments have shown promise in reducing migraine frequency and intensity, with anti-CGRP antibodies being a significant advancement in preventive migraine care. The study focuses on patients with episodic and chronic migraine, including those with medication overuse headache, to better understand how these drugs perform outside controlled clinical trials. The study observes patients receiving various innovative drugs approved for migraine prevention or acute treatment. Anti-CGRP monoclonal antibodies such as erenumab, fremanezumab, galcanezumab, and eptinezumab are evaluated along with oral gepants like atogepant and rimegepant. The study also includes lasmiditan, a ditan for acute migraine attacks, and a combination of sumatriptan and naproxen for those whose migraine does not respond to sumatriptan alone. Data collection integrates treatments as they are used in standard clinical practice. Participants will be monitored over time with assessments at 4, 8, 12, 24, and 48 weeks after starting treatment to measure migraine day frequency reductions and other outcomes such as pain relief, symptom improvement, disability, medication use, and patient perception. Safety and tolerability are also tracked. The study uses questionnaires and clinical evaluations to gather comprehensive information on treatment effects in a real-life setting, with the goal of informing future migraine management strategies.

i-NEED: NEw migrainE Drugs Database