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800 patients, 3 years: mapping the mystery of rare headache attacks

NCT ID NCT07812740

Knowledge-focused Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers at six Italian headache centers are following about 800 adults with trigeminal autonomic cephalalgias, a group of rare headaches that includes cluster headache, paroxysmal hemicrania, SUNCT, SUNA, and hemicrania continua. The study observes routine care rather than assigning any experimental treatment. Over up to three years, participants attend regular visits and researchers record attack frequency, pain intensity, symptoms, treatments used, and how the condition changes over time.

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 the study maps which treatments work best for each headache subtype, doctors could match patients to more effective care and predict who is likely to improve or worsen.
What could go wrong
This is an observational study, so it cannot prove that any treatment causes improvement. Results may reflect the habits of six Italian centers and may not apply to patients elsewhere.

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 800 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2032

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

Adult outpatients with an ICHD-3 diagnosis of trigeminal autonomic cephalalgia (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) evaluated at specialized headache centers participating in the study.

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 18 years or older. * Diagnosis of trigeminal autonomic cephalalgia (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) according to ICHD-3 criteria. * Ability to provide written informed consent. * Availability for longitudinal follow-up and data collection. Exclusion Criteria: * Secondary headache disorders. * Uncertain or unconfirmed diagnosis of a trigeminal autonomic cephalalgia. * Severe cognitive impairment or psychiatric condition interfering with reliable data collection. * Any condition that, in the investigator's judgment, may compromise participation or follow-up.

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Conditions

The condition(s) this trial relates to.

cluster headache syndrome hemicrania continua paroxysmal Hemicrania SUNCT syndrome trigeminal autonomic cephalalgia

As listed by the trial registrant

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

Cluster headache Hemicrania continua Paroxysmal hemicrania Short lasting unilateral neuralgiform headache attacks SUNCT Trigeminal autonomic cephalalgias

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

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, MI, 20133, Italy

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