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Can a simple test predict the best migraine drug for you?

NCT ID NCT04503083

Knowledge-focused Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study aimed to find biological markers that could predict which migraine patients respond best to a new class of drugs called CGRP monoclonal antibodies. Researchers studied 243 adults with severe migraine, using genetic, brain imaging, and other tests. The goal is to personalize treatment, improve outcomes, and reduce healthcare costs.

What this could mean

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

Active substance
CGRP monoclonal antibodies
What this could lead to
If successful, this could help doctors predict which migraine patients will benefit from CGRP antibody treatments, saving time and money.
What could go wrong
This is an observational study, not a treatment trial. The biomarkers identified may not prove reliable in practice, and the 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

243 people

The number who actually took part.

Started

Jan 2021

Finished

Jan 2024

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

Migraine patients and Healthy controls. The Health controls will be recruited among hospital staff and non-related acquaintances of the patients. All patients enrolled in the study will be treated with CGRP-targeting mABs according to the indications approved by their National regulatory bodies

Ages

25 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Migraine patients * Adults between 25 and 55 years of age of both gender; * European background; * Patients diagnosed with high-frequency migraine (HFM) 8 or more migraine days days/month) or CM with or without aura (\>15 headache days migraine/month, of which 8 have migraine characteristics) according to the International Classification of Headache Disorders, 3rd edition, (ICHD-3); * Females have to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control. Healthy controls * Adults between 25 and 55 years of age of both genders; * European background; * Absence of any past or first-degree familial history of recurrent primary or secondary headache disorders. Exclusion Criteria: For the clinical population: * Headache on more than 25 days/month in the last 3 months; * Medication overuse according to the ICHD-3 criteria. For the entire study population (migraine and healthy controls) * Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease); * Evidence of drug, smoking or alcohol abuse or dependence within 12 months prior to V1, based on medical records or patient self-report. An alcohol consumption \>100mg/week will be considered an abuse; * Pregnant or breastfeeding women; * Women of childbearing potential, defined as all women physiologically capable of becoming pregnant who are not on contraception; * Concomitant use of other migraine preventive drugs that may interfere with the endpoints of the study.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

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

Migraine

Contacts and locations

Locations

  • Headache Research Group Vall d'Hebron Institute of Research

    Barcelona, Catalonia, 8009, Spain

  • Headache Science Center

    Pavia, 27100, Italy

  • Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20357, Germany

More trials for these conditions

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