Italian Trigeminal Autonomic Cephalalgias Assessment Study

NCT07812740 | Recruiting

• 1 other identifier: ITACA
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trigeminal Autonomic Cephalalgias; Cluster Headache; Paroxysmal Hemicrania; SUNCT; Hemicrania Continua; Short Lasting Unilateral Neuralgiform Headache Attacks

Keywords

trigeminal autonomic cephalalgias; TACs; cluster headache; paroxysmal hemicrania; SUNCT; SUNA; hemicrania continua; real-world data

Outcome Measures

Primary Outcomes (16)

• Baseline and routine follow-up visits through 3 years after enrollment

  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.

  3 years

• Duration of individual headache attacks

  Typical duration of headache attacks, expressed in minutes, assessed from headache diary data when available or from clinical history collected at study visits.

  3 years

• Headache attack pain intensity assessed using the 11-point Numerical Rating Scale

  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.

  3 years

• Number of participants with cranial autonomic symptoms

  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.

  3 years

• Number of participants with premonitory symptoms

  Number and percentage of participants reporting one or more premonitory symptoms associated with their trigeminal autonomic cephalalgia.

  3 years

• Number of participants with postdromal symptoms

  Number and percentage of participants reporting one or more postdromal symptoms associated with their trigeminal autonomic cephalalgia.

  3 years

• Number of participants with a circadian attack pattern

  Number and percentage of participants reporting a recurrent within-day temporal pattern in the occurrence of headache attacks.

  3 years

• Number of participants with a circannual attack pattern

  Number and percentage of participants reporting a recurrent seasonal or annual temporal pattern in the occurrence of headache attacks.

  3 years

• Number of participants by disease-course category

  Number and percentage of participants classified according to the applicable trigeminal autonomic cephalalgia disease-course category, including episodic and chronic forms where applicable.

  3 years

• Number of participants with a transition in disease-course category

  Number and percentage of participants who transition between applicable disease-course categories, including transitions between episodic and chronic forms where applicable.

  3 years

• Number of participants receiving each acute treatment

  Number and percentage of participants receiving each type of acute treatment for trigeminal autonomic cephalalgia in routine clinical practice.

  3 years

• Number of participants receiving each preventive treatment

  Number and percentage of participants receiving each type of preventive treatment for trigeminal autonomic cephalalgia in routine clinical practice.

  3 years

• Number of participants initiating a new preventive treatment

  Number and percentage of participants who initiate a new preventive treatment during follow-up.

  3 years

• Number of participants switching preventive treatment

  Number and percentage of participants who switch from one preventive treatment to another during follow-up.

  3 years

• Number of participants discontinuing preventive treatment

  Number and percentage of participants who discontinue a preventive treatment during follow-up. Reasons for discontinuation will be categorized where available.

  3 years

• Duration of preventive treatment retention

  Time from initiation of a preventive treatment to permanent discontinuation of that treatment, expressed in months.

  3 years

Secondary Outcomes (27)

• Change from baseline in weekly attack frequency during preventive treatment

  3 years

• Number of participants achieving at least a 50% reduction in weekly attack frequency

  3 years

• Change from baseline in days per week requiring acute headache medication

  3 years

• Number of participants achieving sustained attack remission

  3 years

• Number of participants experiencing adverse events during preventive treatment

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult outpatients with an ICHD-3 diagnosis of trigeminal autonomic cephalalgia (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) evaluated at specialized headache centers participating in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead
• University of Modena and Reggio Emilia: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Università degli Studi dell'Aquila: collaborator
• University of Roma La Sapienza: collaborator
• Pavia IRCCS Mondino di Pavia: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, MI, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Trigeminal Autonomic Cephalalgias; Cluster Headache; Paroxysmal Hemicrania

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Licia Grazzi, MD

  Fondazione IRCCS Istituto Neurologico C. Besta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Licia Grazzi, MD

CONTACT

+ 02 2394; licia.grazzi@istituto-besta.it

Danilo A Montisano, MD

CONTACT

02.2394; danilo.montisano@istituto-besta.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: September 10, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2032
• Last Updated: September 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)