RecruitingNCT06459648

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

Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Enrollment

350 participants

Start Date

Apr 26, 2023

Study Type

OBSERVATIONAL

Conditions

Migraine

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

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 Criteria6

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.

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Interventions

OTHERHeadache record

The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.

OTHERScales

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.

DRUGMonoclonal antibody anti-CGRP

Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab