i-NEED: NEw migrainE Drugs Database

Launched by IRCCS SAN RAFFAELE ROMA · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial, called i-NEED, is studying new treatments for different types of migraine headaches, including episodic migraine (which happens less often), chronic migraine (which happens more than 15 days a month), and headaches caused by taking too much migraine medication. The focus is on medications called anti-CGRP monoclonal antibodies and gepants, which are newer drugs designed to prevent and treat migraines more effectively and with fewer side effects than older treatments. These medicines have shown promising results in reducing the number of migraine days and working quickly, often within the first week of treatment.

People eligible to join the study are adults aged 18 and older who have frequent migraines—at least 8 days of disabling migraine per month—or chronic migraine as diagnosed by standard criteria. Participants should not have other types of headaches, certain vascular diseases, or known allergies to the study medications. If you join, you can expect to receive one of these new migraine treatments and be monitored to see how well the medication works and how well you tolerate it. This trial aims to better understand who benefits most from these treatments and how to best use them to improve migraine care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age more or equal 18 years;
• • Males and females;
• • Willingness to sign the informed consent;
• • Episodic migraine for the use of drug indicated for migraine attack
• • High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;
• • Chronic migraine, according to the ICHD-III criteria;
• Exclusion Criteria:
• • Other headaches different than migraine;
• • Known intolerance to the eccipients;
• • Vascular disease or Raynaud.