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Thousands to test new migraine meds in largest Real-Life study

NCT ID NCT07103694

Disease control Sponsor: IRCCS San Raffaele Roma 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 2,641 people with episodic or chronic migraine to see how well newer drugs—like monoclonal antibodies, gepants, ditans, and a sumatriptan-naproxen combo—work in everyday life. Researchers will track monthly migraine days, pain relief within 2 hours, and any side effects. The goal is to understand real-world effectiveness and safety beyond controlled trials.

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 2,641 people

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

Started

Mar 2022

Expected to finish

Dec 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

Eligible patients include * adults (equal or more 18 years) * episodic or chronic migraine diagnosis, * treated with preventive or acute treatment drugs

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: * Age more or equal 18 years; * Males and females; * Willingness to sign the informed consent; * Episodic migraine for the use of drug indicated for migraine attack * High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months; * Chronic migraine, according to the ICHD-III criteria; Exclusion Criteria: * Other headaches different than migraine; * Known intolerance to the eccipients; * Vascular disease or Raynaud.

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Conditions

The condition(s) this trial relates to.

Headache Disorders, Secondary migraine disorder

As listed by the trial registrant

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

Chronic migraine Episodic migraine Medication overuse headache

How to take part

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

  1. The places running it

    2 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

  • IRCCS San Raffaele

    RECRUITING

    Rome, Italy, 00163, Italy

  • Istituto Auxologico Italiano IRCCS

    RECRUITING

    Milan, Italy, 20145, Italy

More trials for these conditions

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