Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
NCT Number: NCT06459648
Acronym: PREDI-CGRP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine
Interventions: OTHER: Headache record|OTHER: Scales|DRUG: Monoclonal antibody anti-CGRP
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-26
Completion Date: 2025-12
Locations: Hospital Clínico Universitario Lozano Blesa, Zaragoza, Aragón, 50009, Spain|Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, 39008, Spain|Hospital Clínico Universitario de Valladolid, Valladolid, Castilla Y León, 47010, Spain|Hospital Universitari Vall d'Hebron Research Institute, Barcelona, Cataluña, 08035, Spain|Hospital Universitario Politécnico La Fe, Valencia, Comunidad Valenciana, 46026, Spain|Hospital Universitario Donostia, Donostia, País Vasco, 20014, Spain|Hospital Universitario de La Princesa, Madrid, 28006, Spain

Summary:
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.

Primary Outcome Measures: 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)., From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary Outcome Measures: 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., 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., 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., 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., 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., From the beginning of treatment, which is the initial visit, to 18 months of follow-up