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.
Study Type
OBSERVATIONAL
Enrollment
350
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
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain
RECRUITINGHospital Universitario Donostia
Donostia / San Sebastian, Basque Country, Spain
RECRUITINGHospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
RECRUITINGHospital Clínico Universitario de Valladolid
Valladolid, Castille and León, Spain
RECRUITINGHospital Universitari Vall d'Hebron Research Institute
Barcelona, Catalonia, Spain
RECRUITINGHospital Universitario de La Princesa
Madrid, Madrid, Spain
RECRUITINGHospital Universitario Politécnico La Fe
Valencia, Valencia, Spain
RECRUITINGBiomarkers 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.