Migraine Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
View:

• 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

Locations
Other Locations
Italy
Headache Science & Neurorehabilitation Unit
RECRUITING
Pavia
Contact Information
Primary
Roberto De Icco
roberto.deicco@mondino.it
00390382380425
Backup
Cinzia Fattore
cinzia.fattore@mondino.it
00390382380385
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2026-05
Participants
Target number of participants: 100
Treatments
Responders
Patients with high frequency episodic or chronic migraine undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway (mAbs) who obtained a reduction in monthly migraine days equal or higher than 50% compared to pre-treatment values.
NON-Responders
Patients with high frequency episodic or chronic migraine undergoing mAbs treatment who obtained a reduction in monthly migraine days \< 50% compared to pre-treatment values.
Related Therapeutic Areas
Sponsors
Collaborators: University of L'Aquila
Leads: IRCCS National Neurological Institute C. Mondino Foundation

This content was sourced from clinicaltrials.gov