A real-world look at trigeminal autonomic cephalalgias in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ITACA is a prospective, multicenter, observational cohort study conducted in routine outpatient practice at six Italian headache centers. It plans to enroll about 800 adults diagnosed with trigeminal autonomic cephalalgias according to ICHD-3 and follow them for up to three years, collecting data on clinical features, treatment patterns, effectiveness, tolerability, comorbidities, lifestyle factors, and patient-reported outcomes. No experimental treatment is given; care decisions are made by treating physicians as part of standard clinical practice. Follow-up occurs at baseline and roughly every 3–6 months, with retrospective data collection at baseline to enhance disease history characterization. The goal is to improve phenotypic understanding and evidence-based treatment selection for TACs in real-world settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione IRCCS Istituto Neurologico Carlo Besta
  Milan, Mi, Italy Recruiting

Study contacts

• Principal investigator: Licia Grazzi, MD — Fondazione IRCCS Istituto Neurologico C. Besta
• Study coordinator: Licia Grazzi, MD
• Email: licia.grazzi@istituto-besta.it
• Phone: + 02 2394

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.