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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with migraine under treatment with monoclonal antibodies against CGRP | Patients with diagnosis of episodic or chronic migraine who, under the criteria of their neurologist and according to the clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (Galcanezumab, Fremanezumab, Eptinezumab) or else its receptor (Erenumab) will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Headache record | Other | The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Beatriz Gago Veiga | Contact | +34 915202416 | anabeatriz.gago@salud.madrid.org | |
| Iris Fernández Lázaro | Contact | irisfdezlaz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ana Beatriz Gago Veiga | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | Aragon | 50009 | Spain |
Individual participant data (IPD) will not be shared with other researchers. This decision is based on data protection and confidentiality requirements in accordance with applicable European and national regulations (including GDPR). Given that this is a multicentre observational study conducted in routine clinical practice, access to IPD is restricted to the study investigators for the purposes of the predefined analyses.
Any potential secondary use of the dataset would only be considered in fully anonymized form and subject to prior ethical approval and compliance with applicable data protection legislation.
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The samples collected from the patients in the study are blood and neuroimaging samples, specifically, brain MRIs without contrast. Thanks to the blood samples, serum, plasma as well as peripheral blood mononuclear cells (PBMCs) will be analyzed. This analysis will allow measurement of CGRP levels in blood, genome sequencing to obtain the genotype of each participant and estimate their polygenic risk of disease, methylome sequencing to obtain the methylation profile of the CpG islands described in human chips and finally data of transcriptomics, specifically miRNA.
| Scales | Other | 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 |
|
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 |
| Hospital Universitario Donostia | Recruiting | Donostia / San Sebastian | Basque Country | 20014 | Spain |
|
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
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| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | Castille and León | 47010 | Spain |
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| Hospital Universitari Vall d'Hebron Research Institute | Recruiting | Barcelona | Catalonia | 08035 | Spain |
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| Hospital Universitario de La Princesa | Recruiting | Madrid | Madrid | 28006 | Spain |
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| Hospital Universitario Politécnico La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
|
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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