Status:
RECRUITING
Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborating Sponsors:
University of L'Aquila
Conditions:
Migraine Disorders
Chronic Migraine
Eligibility:
All Genders
18-75 years
Brief Summary
The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments, including monoclonal antibodies (mAbs) targeting calcitonin ...
Detailed Description
High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI) are widely available as powerful means to non-invasively study brain connectivity features in migraine patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06562413
Start Date
May 10 2023
End Date
May 1 2026
Last Update
August 20 2024
Active Locations (1)
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1
Headache Science & Neurorehabilitation Unit
Pavia, Italy, 27100