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Migraine crystal ball: study aims to predict treatment success

NCT ID NCT06459648

Knowledge-focused Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study is looking for ways to predict which migraine patients will respond well to a class of drugs called anti-CGRP monoclonal antibodies. Researchers will analyze clinical, biological, and brain imaging data from 350 adults with frequent migraines. The goal is to find biomarkers that help doctors choose the right treatment from the start, reducing trial-and-error and improving patients' quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anti-CGRP monoclonal antibodies (Erenumab, Galcanezumab, Fremanezumab, Eptinezumab)
What this could lead to
If successful, this could help doctors predict which migraine treatment will work best for each patient, saving time and improving quality of life.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear predictors, and results may not apply to all migraine patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Headache migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clínico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, Aragon, 50009, Spain

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, Castille and León, 47010, Spain

  • Hospital Universitari Vall d'Hebron Research Institute

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario Donostia

    RECRUITING

    Donostia / San Sebastian, Basque Country, 20014, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Politécnico La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario de La Princesa

    RECRUITING

    Madrid, Madrid, 28006, Spain

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