Italian Trigeminal Autonomic Cephalalgias Assessment Study

Condition(s) studied

Study 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

Primary outcome measure(s)

• Baseline and routine follow-up visits through 3 years after enrollment — 3 years
  Number of headache attacks occurring during a 7-day period, assessed from headache diary data when available or from clinical history collected at study visits. Values will be recorded according to the participant's trigeminal autonomic cephalalgia subtype.
• Duration of individual headache attacks — 3 years
  Typical duration of headache attacks, expressed in minutes, assessed from headache diary data when available or from clinical history collected at study visits.
• Headache attack pain intensity assessed using the 11-point Numerical Rating Scale — 3 years
  Pain intensity will be rated on an 11-point Numerical Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
• Number of participants with cranial autonomic symptoms — 3 years
  Number and percentage of participants reporting cranial autonomic symptoms associated with headache attacks. Symptom categories collected include lacrimation, conjunctival injection, nasal congestion, ptosis, and miosis.
• Number of participants with premonitory symptoms — 3 years
  Number and percentage of participants reporting one or more premonitory symptoms associated with their trigeminal autonomic cephalalgia.
• Number of participants with postdromal symptoms — 3 years
  Number and percentage of participants reporting one or more postdromal symptoms associated with their trigeminal autonomic cephalalgia.
• Number of participants with a circadian attack pattern — 3 years
  Number and percentage of participants reporting a recurrent within-day temporal pattern in the occurrence of headache attacks.
• Number of participants with a circannual attack pattern — 3 years
  Number and percentage of participants reporting a recurrent seasonal or annual temporal pattern in the occurrence of headache attacks.
• Number of participants by disease-course category — 3 years
  Number and percentage of participants classified according to the applicable trigeminal autonomic cephalalgia disease-course category, including episodic and chronic forms where applicable.
• Number of participants with a transition in disease-course category — 3 years
  Number and percentage of participants who transition between applicable disease-course categories, including transitions between episodic and chronic forms where applicable.
• Number of participants receiving each acute treatment — 3 years
  Number and percentage of participants receiving each type of acute treatment for trigeminal autonomic cephalalgia in routine clinical practice.
• Number of participants receiving each preventive treatment — 3 years
  Number and percentage of participants receiving each type of preventive treatment for trigeminal autonomic cephalalgia in routine clinical practice.
• Number of participants initiating a new preventive treatment — 3 years
  Number and percentage of participants who initiate a new preventive treatment during follow-up.
• Number of participants switching preventive treatment — 3 years
  Number and percentage of participants who switch from one preventive treatment to another during follow-up.
• Number of participants discontinuing preventive treatment — 3 years
  Number and percentage of participants who discontinue a preventive treatment during follow-up. Reasons for discontinuation will be categorized where available.
• Duration of preventive treatment retention — 3 years
  Time from initiation of a preventive treatment to permanent discontinuation of that treatment, expressed in months.

Trial sites (1)

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