Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
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