Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
PREDI-CGRP
Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
1 other identifier
observational
350
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2023
CompletedFirst Submitted
Initial submission to the registry
June 5, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedSeptember 24, 2025
September 1, 2025
2.6 years
June 5, 2024
September 23, 2025
Conditions
Keywords
Outcome Measures
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).
From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary Outcomes (5)
Sustained response factors
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
From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Non-maintained pharmacological response relation with biomarkers
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
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
From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Study Arms (1)
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.
Interventions
The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
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.
Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country, 20014, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, 47010, Spain
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, Catalonia, 08035, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, 28006, Spain
Hospital Universitario Politécnico La Fe
Valencia, Valencia, 46026, Spain
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Beatriz Gago Veiga
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2024
First Posted
June 14, 2024
Study Start
April 26, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
September 24, 2025
Record last verified: 2025-09