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New daily pill could cut migraine days in half

NCT ID NCT06414044

Disease control Sponsor: University of Florence 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 500 Italian adults with migraine to see how well the daily pill atogepant works in everyday life. Researchers will measure changes in monthly migraine days over a year. The goal is to find out if atogepant is a safe and effective preventive treatment for people with episodic or chronic 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 show that atogepant is a safe and effective daily pill to prevent migraines in real-world patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also limited to Italian patients, so findings may not apply to everyone.

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

500 people

The number who actually took part.

Started

May 2024

Expected to finish

Apr 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

Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for atogepant use for migraine preventive treatment.

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: * Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III); * At least 3 monthly migraine days; * Good compliance to study procedures; * Availability of headache diary at least of the preceding months before enrollment. Exclusion Criteria: * Subjects with contraindications for use of gepants; * Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments; * medical comorbidities that could interfere with study results; * Pregnancy and breastfeeding.

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Conditions

The condition(s) this trial relates to.

Headache Headache Disorders, Secondary migraine disorder migraine with aura migraine without aura Pain

As listed by the trial registrant

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

Chronic migraine Migraine Migraine with aura Migraine without aura

Contacts and locations

Locations

  • Fondazione Policlinico Campus Bio-Medico

    Roma, 00128, Italy

  • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

    Florence, 50134, Italy

More trials for these conditions

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