About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 and 65 years.
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.
Disqualifiers
Patients who present with another type of non-migraine headache, with the exception of headache due to excessive use of analgesic medication.
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.
Trial population
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: * La Princesa University Hospital * Vall d'Hebron University Hospital * Marqués de Valdecilla University Hospital * Valladolid University Clinical Hospital * Donostia University Hospital * Lozano Blesa University Clinical Hospital * La Fe Polytechnic University Hospital
Trial design
Cohort
Prospective
Treatments tested in this trial
Headache record
Other interventionThe patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
Scales
Other interventionEach 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
DrugErenumab, Galcenazumeb, Fremanezumab, Eptinezumab
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
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.
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 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.
Sponsors and contacts
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