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Italian Trigeminal Autonomic Cephalalgias Assessment Study

Recruitingn/aAges 18 Years - anyAllFondazione I.R.C.C.S. Istituto Neurologico Carlo …
NCT07812740 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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