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Clinical Trials in Spain / NCT06459648
Active, not recruiting Observational

Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies

NCT06459648 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Phase
Observational
Started
2023-04-26
Last updated
2026-09-25

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

Headache recordScalesMonoclonal antibody anti-CGRP

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * 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: * 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. * 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.

Primary outcome measure(s)

  • Biomarkers of positive initial response to monoclonal antibodies — From the beginning of treatment, which is the initial visit, to 18 months of follow-up
    Establish clinical, demographic, transcriptomic, genetic, molecular and/or radiological characteristics that allow predicting a positive initial response to monoclonal antibodies (biomarkers of therapeutic response).

Trial sites (7)

FacilityCityRegionStatus
Hospital Clínico Universitario Lozano Blesa Zaragoza Aragon
Hospital Universitario Donostia Donostia / San Sebastian Basque Country
Hospital Universitario Marqués de Valdecilla Santander Cantabria
Hospital Clínico Universitario de Valladolid Valladolid Castille and León
Hospital Universitari Vall d'Hebron Research Institute Barcelona Catalonia
Hospital Universitario de La Princesa Madrid Madrid
Hospital Universitario Politécnico La Fe Valencia Valencia

More Fundación de Investigación Biomédica - Hospital Universitario de La Princesa trials in Spain

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Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol Active, not recruiting
Migraine Attack Pain Phase Prediction Study Active, not recruiting

Other trials for the same condition

A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine Active, not recruiting
Migraine and Endometriosis: The FEMININE Study Starting soon
Migraine Attack Pain Phase Prediction Study Active, not recruiting
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects Recruiting
Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06459648 on ClinicalTrials.gov ↗ ← All trials in Spain