Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments
Recruiting now
Conditions studied: Migraine Disorders, Chronic Migraine, Episodic Migraine
In brief
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 gene-related peptide (CGRP) pathway (NON-responders). Primary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days \>/= than 50% (namely Responders) and those who will not (namely Responders). The 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI).
Key facts
- Study ID
- NCT06562413
- Run by
- IRCCS National Neurological Institute "C. Mondino" Foundation
- People needed
- 100
- Starts
- 2023-05-10
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2024-08-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Headache Science & Neurorehabilitation Unit — Pavia, Italy (enrolling)
Full record on ClinicalTrials.gov
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