NCT06562413 Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments
| NCT ID | NCT06562413 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation |
| Condition | Migraine Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-05-10 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06562413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Migraine Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06562413 currently recruiting?
Yes, NCT06562413 is actively recruiting participants. Contact the research team at roberto.deicco@mondino.it for enrollment information.
Where is the NCT06562413 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06562413 clinical trial?
NCT06562413 is sponsored by IRCCS National Neurological Institute "C. Mondino" Foundation. The trial plans to enroll 100 participants.
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