MigrainePREDI-CGRPNCT06459648
Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
An observational study of Migraine, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 7 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Headache record, Scales and Monoclonal antibody anti-CGRP
- How many people
- 350 participants
- Where
- 7 sitesSpain
- Study dates
- 26 Apr 2023to Dec 2026
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, Catalonia, 08035
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country, 20014
Hospital Universitario de La Princesa
Madrid, Madrid, 28006
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Politécnico La Fe
Valencia, Valencia, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, 47010
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, 50009
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Headache record, Scales, Monoclonal antibody anti-CGRP
- Keywords
- Migraine, headache, antibodies, antibody, monoclonal antibody, anti-cgrp, anti cgrp, cgrp, prediction, treatmen, migraine treatment, treatment with anti-CGRP monoclonal antibodies, anti-cgrp antibodies, anti-cgrp antibody, anti-cgrp monoclonal antibodies, migraine and antibodies, migraine and cgrp
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headache recordOther
The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
ScalesOther
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-CGRPDrug
Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Headache record; Other: Scales; Drug: Monoclonal antibody anti-CGRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary outcomes (5)
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.
Measured: 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
To quantify the proportion of patients who present a sustained response after discontinuation of the anti-CGRP antibody.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start26 Apr 2023
- Primary completion31 Jul 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Gago, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Investigators
- Ana Beatriz Gago Veiga, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459648
- Sponsor's protocol ID
- PI 23- 3054
- Acronym
- PREDI-CGRP
- Status last verified
- Jan 2026
- First submitted
- 5 Jun 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
- ClinicalTrials.gov ID
- NCT06459648
- Acronym / sponsor ID
- PREDI-CGRP / PI 23- 3054
- Conditions
- Migraine
- Keywords
- Migraine, headache, antibodies, antibody, monoclonal antibody, anti-cgrp, anti cgrp, cgrp
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with migraine under treatment with monoclonal antibodies against CGRP | – | Other: Headache record, Other: Scales, Drug: Monoclonal antibody anti-CGRPPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Headache recordThe patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication. | Other | Patients with migraine under treatment with monoclonal antibodies against CGRP |
| ScalesEach 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. | Other | Patients with migraine under treatment with monoclonal antibodies against CGRP |
| Monoclonal antibody anti-CGRPErenumab, Galcenazumeb, Fremanezumab, Eptinezumab | Drug | Patients with migraine under treatment with monoclonal antibodies against CGRP |
Primary outcome
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).
5 secondary outcomes
Sustained response factors
Time frame: 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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Beatriz Gago Veiga principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.