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Italian Trigeminal Autonomic Cephalalgias Assessment Study

Study acronym: ITACA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Oct 2026 to Sep 15, 2026
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07812740
Lead Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators: University of Modena and Reggio Emilia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università degli Studi dell'Aquila, University of Roma La Sapienza, Pavia IRCCS Mondino di Pavia
Conditions
(from sponsor)		 Trigeminal Autonomic Cephalalgias, Cluster Headache, Paroxysmal Hemicrania, SUNCT, Hemicrania Continua, Short Lasting Unilateral Neuralgiform Headache Attacks
Related terms Cluster Headache, Paroxysmal Hemicrania, Trigeminal Autonomic Cephalalgias
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov