Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
NCT ID: NCT06459648
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
350 participants
OBSERVATIONAL
2023-04-26
2025-12-31
Brief Summary
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Detailed Description
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At each visit, demographic and clinical variables will be collected. In addition, 3 blood tests will be performed corresponding to the beginning of treatment, after 6 months and a month and a half from the last infiltration. Likewise, a brain MRI will be obtained prior to the start of treatment. These blood samples and neuroimaging data will be processed for subsequent analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with migraine under treatment with monoclonal antibodies against CGRP
Patients with diagnosis of episodic or chronic migraine who, under the criteria of their neurologist and according to the clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (Galcanezumab, Fremanezumab, Eptinezumab) or else its receptor (Erenumab) will be included.
Headache record
The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
Scales
Each patient performs different scales that measure the impact of the migraine on their daily life as well as the disability it may be causing. In turn, each patient performs different scales that measure associated comorbidities such as depression, anxiety or insomnia.
Monoclonal antibody anti-CGRP
Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab
Interventions
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Headache record
The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
Scales
Each patient performs different scales that measure the impact of the migraine on their daily life as well as the disability it may be causing. In turn, each patient performs different scales that measure associated comorbidities such as depression, anxiety or insomnia.
Monoclonal antibody anti-CGRP
Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab
Eligibility Criteria
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Inclusion Criteria
* Caucasian ethnicity.
* Patients diagnosed with migraine with and without high-frequency episodic aura (more than 8 days of migraine per month) or chronic by a neurologist expert in headaches and according to the criteria proposed in the International Classification of Headache Diseases, 3rd edition (ICHD- 3).
* Have at least one year of history of migraine.
* Patients must maintain stable preventive treatment in the previous month and not have received botulinum toxin in the month prior to starting the monoclonal antibody.
* Patients able to describe their clinical situation and the characteristics of their headache.
* Grant your informed consent.
Exclusion Criteria
* Neurological focus in the examination.
* Pregnancy or breastfeeding period.
* Patients with cognitive deficiency or pathology that may prevent or hinder the correct completion of the study.
* Patients who require changes in preventive treatment during the first 6 months after starting treatment with monoclonal antibodies.
* Patients who present any significant adverse effect that requires withdrawal or change of anti-CGRP drug.
18 Years
65 Years
ALL
No
Sponsors
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Responsible Party
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Principal Investigators
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Ana Beatriz Gago Veiga
Role: PRINCIPAL_INVESTIGATOR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Locations
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Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, Spain
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, Catalonia, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Hospital Universitario Politécnico La Fe
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Gabriel Gárate
Role: backup
Yésica González Osorio
Role: backup
Edoardo Caronna
Role: backup
Other Identifiers
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PI 23- 3054
Identifier Type: -
Identifier Source: org_study_id
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