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

ConditionMigraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorFundación de Investigación Biomédica - Hospital Universitario de La Princesa

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Headache record

    Other intervention

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

  • Scales

    Other intervention

    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

    Drug

    Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Patients with migraine under treatment with monoclonal antibodies against CGRP3 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
From the beginning of treatment, which is the initial visit, to 18 months of follow-up

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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