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Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments

NCT06562413 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-08-20

No results posted yet for this study

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).

Conditions

  • Migraine Disorders
  • Chronic Migraine
  • Episodic Migraine

Interventions

DRUG

MAbs

Monthly or quarterly mAbs administration

Sponsors & Collaborators

  • University of L'Aquila

    collaborator OTHER

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2026-02-28
Completion
2026-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06562413 on ClinicalTrials.gov