Searching for Novel Therapeutic Approaches 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 exploring new treatment options for people who suffer from chronic or episodic migraines but have not found relief with existing medications. Researchers believe that some patients who do not respond to current migraine treatments may have issues with a system in the body called the endocannabinoid system, which is thought to help regulate pain. The trial will focus on patients who have not seen a significant reduction in their migraine days after three months of treatment.

To join the study, participants must be between 18 and 75 years old and have either chronic or episodic migraines, specifically having eight or more headache days each month despite trying at least three other migraine prevention medications. Participants will undergo evaluations to see how these new treatment approaches affect their migraines and overall health. It’s important to note that individuals with certain psychiatric or neurological conditions, other headache disorders, or significant medical issues will not be eligible for this trial. If you or someone you know fits the criteria and is looking for new options, this trial might be a good opportunity to consider.

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)
• • clinically significant medical conditions
• • chronic pain conditions
• • alcohol and/or drug abuse
• • pregnancy or lactation