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Scientists track the earliest clues of a migraine before pain begins

NCT ID NCT07681466

Knowledge-focused Sponsor: University of Roma La Sapienza 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study investigates the sequence of early warning signs, called premonitory symptoms, that occur before a migraine headache starts. Researchers will follow 500 adults with migraine who will record their symptoms using an electronic diary for up to five attacks. The goal is to identify which symptoms appear first and how long before the headache they occur, which could help people better predict and manage their migraines.

What this could mean

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

What this could lead to
If successful, this could help people with migraine recognize early signs and take preventive action sooner.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to immediate clinical changes, and results depend on accurate self-reporting.

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 500 people

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

Started

Mar 2026

Expected to finish

Sep 2027

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

Prospective, longitudinal, multicentric study on patients with migraine attending the outpatient clinic of Italian Headache centres who will meet the inclusion and exclusion criteria.

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: * Diagnosis of episodic (EM) or chronic migraine (CM) or CM with medication overuse headache (MOH) according to ICHD-III criteria; * Age between 18 and 65 years; * At least 2 migraine days (MMD) in the month preceding the inclusion; * Migraine history of at least 12 months prior to inclusion * Signed written informed consent. Exclusion Criteria: * History or current diagnosis of secondary headache disorders as defined by ICHD-III; * History of other neurological comorbidities or major psychiatric disorders; * History of migraine for \< 12 months prior to the inclusion; * Opioid overuse according to the ICHD-III criteria; * Pregnancy or breastfeeding.

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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

How to take part

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

  1. The places running it

    1 site. 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

  • Sapienza University of Rome, Polo Pontino, centro cefalee, ICOT

    RECRUITING

    Latina, Italy, 04100, Italy

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