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Real-world study tests migraine drug atogepant over 12 months in tough-to-treat patients

NCT ID NCT07699549

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study follows over 500 adults with migraine who have not responded well to other preventive treatments. Participants take atogepant as prescribed by their doctor and are monitored for a year to see how well it reduces headache and migraine days, and how long they stay on the medication. The goal is to understand if atogepant works in everyday clinical practice for people with a high burden of migraine.

What this could mean

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

Active substance
atogepant
What this could lead to
If successful, this could confirm atogepant as a reliable long-term preventive option for people with hard-to-treat migraine.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and real-world variability. It is also limited to a specific population with prior treatment failures.

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

513 people

The number who actually took part.

Started

Jun 2024

Finished

Mar 2026

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

Adult patients with migraine, according to ICHD-3 criteria, initiating preventive treatment with atogepant in routine clinical practice were included in this prospective, multicentre, open-label observational study. No masking was applied. Patients were recruited from headache units and neurology departments across Spain: * Hospital Universitario de La Princesa * Hospital Universitario de Fuenlabrada * Fundación Jiménez Díaz-UTE * Hospital de Torrejón * Hospital Virgen del Puerto * Hospital Clínico San Carlos * Hospital Universitario 12 de Octubre * Hospital Clínico Universitario de Valladolid (IBIoVALL) * Hospital Universitario La Paz * Hospital Clínico Universitario Lozano Blesa * Hospital Universitario de Getafe * Hospital Ruber Internacional Treatment initiation with atogepant for migraine prevention was determined by the treating neurologist according to clinical practice guidelines and standard of care.

Ages

18 years and older

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: * Adults aged ≥18 years. * Diagnosis of migraine with or without aura established by a headache specialist according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), including both chronic and episodic migraine. * History of migraine of at least 1 year duration. * Stable preventive migraine treatment (if any) for at least the previous 3 months. * Normal neurological examination. * Fulfilment of national health system reimbursement criteria for atogepant treatment. Exclusion Criteria: * Cognitive impairment or any other condition that, in the investigator's opinion, may prevent the patient from reliably distinguishing prodromal symptoms. * Presence of other active primary or secondary headache disorders, except medication overuse headache or infrequent tension-type headache.

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Conditions

The condition(s) this trial relates to.

Headache headache disorder migraine disorder Prescription Drug Overuse

As listed by the trial registrant

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

Headache Headache, migraine Migraine Migraine disability Migraine disease Migraine disorder Migraine headache

Contacts and locations

Locations

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006, Spain

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