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Massive migraine study aims to unlock secrets of chronic head pain

NCT ID NCT07163416

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This large observational study will follow over 2,000 adults with migraine in Italy for two years. Researchers will collect data on symptoms, treatments, and healthcare use to better understand how migraine evolves and how patients are managed. The goal is to improve diagnosis and care pathways for people with episodic and chronic migraine.

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 registry could reveal better ways to diagnose and treat migraine, improving patient care and reducing healthcare costs.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test new therapies. Results depend on accurate patient reporting and may not apply outside Italy.

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 2,030 people

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

Started

Apr 2021

Expected to finish

Mar 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

The reference population for the registry IGRAINE includes adult patients of both sexes, suffering from episodic or chronic migraine, undergoing treatment at a specialized headache center. At the time of its launch, 46 headache centers distributed throughout Italy will participate in the registry. To ensure its representativeness, the study sample includes 10% of the total number of patients followed at the centers, selected randomly. The registry will be enrolled using the "systematic random" method. Participation in the study will be offered to the first patient at the first visit (incident patient) and to the first patient at the follow-up visit (prevalent patient) of each outpatient day at the clinical center. If the first patient in each category refuses, participation in the study will be offered to the next patient in order of visit in the same category (prevalent or incident). Researchers are advised NOT to skip patients so as not to create a selection bias in the population.

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: * Adult Patients(Age ≥ 18 years) of both sexes * Diagnosis confirmed of episodic migraine ( \<15 days/month ) with or without aura or chronic migraine (\>15days/month) ,with or without headeche due to overuse of analgesics; * Provision of signed and dated the Informed Consent Form before the inclusion in the study Exclusion Criteria: * Patients affected by other forms of primary or secondary headaches or in whom the diagnosis is not certain

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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 disorders

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

  • Head, Irccs San Raffaele Roma S.r.l. - Unità per la cura e la ricerca su cefalee e dolore - Dipartimento di Neurologia, Via di Val di Cannuta 250, 00166 Roma (RM) - Italy

    RECRUITING

    Roma, Roma, 00166, Italy

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