Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments

Launched by IRCCS NATIONAL NEUROLOGICAL INSTITUTE "C. MONDINO" FOUNDATION · Aug 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to learn more about certain types of migraines, especially in patients who have not found relief from at least three different migraine treatments. The researchers want to understand how the brain functions in these patients, specifically comparing those who respond well to a new treatment using monoclonal antibodies (which target a specific pathway involved in migraine) to those who do not see any improvement after three months. By using advanced brain imaging techniques, they hope to identify different brain activity patterns in these two groups.

To participate in this study, individuals must be between 18 and 75 years old and have either chronic or episodic migraines that meet specific criteria. Eligible participants must have experienced at least eight debilitating migraine days each month for the last three months and must not have tried treatments targeting the CGRP pathway before. Throughout the trial, participants will undergo brain scans to observe changes in brain connectivity and will receive the new treatment to see if it helps reduce their migraine days. This research aims to provide insights that could lead to better treatments for patients whose migraines are hard to manage.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • male and female patients aged 18 to 75 years
• • diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria
• • for episodic migraine: 8-14 monthly migraine days in the previous 3 months
• • diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months
• • patients naive to CGRP targeting treatments
• Exclusion Criteria:
• • history of major psychiatric or other neurological conditions
• • diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)
• • changes in ongoing preventive treatment (if any) in the previous 3 months
• • clinically significant medical conditions
• • chronic pain conditions
• • alcohol and/or drug abuse
• • pregnancy or lactation