An observational study in Migraine, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Active, not recruiting at 7 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Observational
Being able to predict each patients response to a specific treatment can mean a significant improvement in socioeconomic costs, but above all in their quality of life. With the present study, the investigators aim to analyze in a combined way different clinical, biological and neuroimaging variables, which allow the clinical staff to anticipate the response to treatment with anti-CGRP monoclonal antibodies in patients with migraine.
The study consists of an initial visit coinciding with the start of treatment, a subsequent visit after 6 months of treatment and finally another after 12 months, coinciding with the end of treatment. In case of worsening after suspension, a clinical visit will be carried out at the time of worsening to evaluate the reintroduction of the drug and in case of reintroduction, a visit will be carried out after 3 months. If patients do not worsen, a visit will be made 6 months after completing treatment.
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.
Patients aged between 18 and 65 years with a diagnosis of episodic or chronic migraine who, at the discretion of their neurologist and according to clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (Galcanezumab, Fremanezumab, Eptinezumab) or its receptor (Erenumab) be included. These patients will come from 7 Headache Units in Spain belonging to the following hospitals:
Exclusion Criteria:
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.
Other: Headache record · Other: Scales · Drug: Monoclonal antibody anti-CGRP
The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
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.
Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab
Biomarkers of positive initial response to monoclonal antibodies
Establish clinical, demographic, transcriptomic, genetic, molecular and/or radiological characteristics that allow predicting a positive initial response to monoclonal antibodies (biomarkers of therapeutic response).
Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Sustained response factors
To analyze sustained response factors at the sociodemographic, clinical, transcriptomic, genetic, molecular and/or radiological level after the suspension of anti-CGRP drugs.
Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Sustained response after discontinuation of the anti-CGRP antibody
To quantify the proportion of patients who present a sustained response after discontinuation of the anti-CGRP antibody.
Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Non-maintained pharmacological response relation with biomarkers
To characterize whether the non-maintained pharmacological response is related to the variables previously characterized as predictors of chronicity.
Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Time until relapse after discontinuation of the anti-CGRP antibody
To determine the time until relapse after discontinuation of the anti-CGRP monoclonal antibody in those patients who, having presented a positive initial response, discontinue it.
Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Biomarkers of patients with high-frequency episodic migraine and chronic migraine
To validate possible transcriptomic, genetic, molecular and/or radiological characteristics that allow differentiation between patients with high-frequency episodic migraine and chronic migraine in a national multicenter cohort.
Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Plan to share: No — Individual participant data (IPD) will not be shared with other researchers. This decision is based on data protection and confidentiality requirements in accordance with applicable European and national regulations (including GDPR). Given that this is a multicentre observational study conducted in routine clinical practice, access to IPD is restricted to the study investigators for the purposes of the predefined analyses. Any potential secondary use of the dataset would only be considered in fully anonymized form and subject to prior ethical approval and compliance with applicable data protection legislation.
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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa