Clinical Trial

Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments

Study acronym: SPHERA_WP1_2

Recruiting

Record status

This record was last updated August 20, 2024 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

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).

Trial Details

NCT Number	NCT06562413
Lead Sponsor	IRCCS National Neurological Institute "C. Mondino" Foundation Collaborators: University of L'Aquila
Conditions	Migraine Disorders, Chronic Migraine, Episodic Migraine
Enrollment	100 participants
Start Date	2023-05-10
Primary Completion	2026-02 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2024-08-20