Biochemical Profiling of Migraine Patients

Launched by IRCCS NATIONAL NEUROLOGICAL INSTITUTE "C. MONDINO" FOUNDATION · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Biochemical Profiling of Migraine Patients," is studying how the body's endocannabinoid system, which plays a role in pain and inflammation, might be affected in people with migraines. Specifically, researchers want to find out if there are differences in certain biological markers between migraine patients who respond well to a new preventive treatment (using monoclonal antibodies aimed at a specific protein) and those who do not. This could help improve future treatments for migraines.

To participate in the trial, individuals must be between the ages of 18 and 75 and have either chronic or episodic migraines, which means they experience a certain number of headache days each month. Participants should have tried several other migraine treatments without success and should not have used treatments targeting the specific protein being studied. If eligible, participants will undergo tests to measure various markers in their body over the course of three months to see how their migraines respond to the new therapy. It's important to note that individuals with certain medical conditions, psychiatric issues, or those who are pregnant or breastfeeding cannot join the study.

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: i) having failed at least 3 classes of migraine preventatives and ii) suffering 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