Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MAbs

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

1
Headache Science & Neurorehabilitation Unit27100, Pavia Italy

Sponsors and collaborators

IRCCS National Neurological Institute "C. Mondino" Foundation

Lead sponsor

University of L'Aquila

Collaborator