RecruitingNCT07812740

Italian Trigeminal Autonomic Cephalalgias Assessment Study

Italian Trigeminal Autonomic Cephalalgias Assessment Study (ITACA)


Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Enrollment

800 participants

Start Date

Oct 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

ITACA is a prospective, multicenter, observational longitudinal cohort study conducted in routine clinical practice at six Italian headache centers. Approximately 800 adults with trigeminal autonomic cephalalgias (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) diagnosed according to ICHD-3 will be enrolled. The study will describe clinical features and real-world treatment patterns and will evaluate treatment effectiveness and tolerability, changes in clinical features over time, comorbidities, lifestyle factors, patient-reported outcomes, and predictors of treatment response and disease progression. No investigational intervention will be assigned; treatments are prescribed by treating physicians as part of routine clinical care. Participants will be assessed at baseline and during routine follow-up visits, approximately every 3-6 months or as clinically indicated, for up to 3 years. Relevant clinical data already available in medical records before enrollment may also be collected to improve baseline characterization and reconstruction of disease course.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with cluster headache, hemicrania continua, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, MI, Italy

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NCT07812740


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