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RECRUITINGOBSERVATIONAL

Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments

Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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) * 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

Treatments Being Tested

DRUG

MAbs

Monthly or quarterly mAbs administration

Locations (1)

Headache Science & Neurorehabilitation Unit
Pavia, Italy