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

September 23, 2025 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
        • Principal Investigator:
          • Sonia Santos-Lasaosa
    • Basque Country
      • Donostia / San Sebastian, Basque Country, Spain, 20014
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
        • Contact:
          • Gabriel Gárate
        • Principal Investigator:
          • Julio Pascual Gómez
    • Castille and León
      • Valladolid, Castille and León, Spain, 47010
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
        • Contact:
          • Yésica González Osorio
        • Principal Investigator:
          • David García Azorín
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron Research Institute
        • Principal Investigator:
          • Patricia Pozo-Rosich
        • Contact:
        • Contact:
          • Edoardo Caronna
    • Madrid
      • Madrid, Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Beatriz Gago Veiga
        • Sub-Investigator:
          • Alicia González Martínez
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario Politecnico La Fe
        • Contact:
        • Principal Investigator:
          • Samuel Díaz Insa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Headache record
The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
Other: 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.
Drug: Monoclonal antibody anti-CGRP
Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers of positive initial response to monoclonal antibodies
Time Frame: 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).
From the beginning of treatment, which is the initial visit, to 18 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained response factors
Time Frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
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
Time Frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
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
Time Frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
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
Time Frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
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
Time Frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Investigators

  • Principal Investigator: Ana Beatriz Gago Veiga, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 23- 3054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized data may be shared upon reasonable request to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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