Actively Recruiting
Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments
Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2024-08-20
100
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
I
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead Sponsor
U
University of L'Aquila
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 to 75 years
- Diagnosis of episodic or chronic migraine according to ICHD-3 criteria
- For episodic migraine: 8 to 14 monthly migraine days in the previous 3 months
- Diagnosis of resistant migraine, having failed at least 3 classes of migraine preventatives and experiencing at least 8 debilitating monthly headache days for at least 3 consecutive months
- Patients naive to CGRP targeting treatments
You will not qualify if you...
- History of major psychiatric or other neurological conditions
- Diagnosis of other primary or secondary headache disorders (sporadic tension-type headache allowed if clearly differentiated from migraine)
- Changes in ongoing preventive treatment in the previous 3 months
- Clinically significant medical conditions
- Chronic pain conditions
- Alcohol and/or drug abuse
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Headache Science & Neurorehabilitation Unit
Pavia, Italy, 27100
Actively Recruiting
Research Team
R
Roberto De Icco
CONTACT
C
Cinzia Fattore
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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