Trigeminal Autonomic CephalalgiasITACANCT07812740
Italian Trigeminal Autonomic Cephalalgias Assessment Study
An observational study of Trigeminal Autonomic Cephalalgias and Cluster Headache, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Autonomic Cephalalgias, Cluster Headache, Paroxysmal Hemicrania
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2026to Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, MI, 20133
Danilo A Montisano, MD, + 39 02.2394, danilo.montisano@istituto-besta.it
About this study
Official title: Italian Trigeminal Autonomic Cephalalgias Assessment Study (ITACA)
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.
Read the detailed description
Trigeminal autonomic cephalalgias are rare and highly disabling primary headache disorders characterized by unilateral pain and ipsilateral cranial autonomic symptoms. Their clinical heterogeneity, frequent misdiagnosis, diagnostic delay, and the limited availability of large longitudinal datasets make accurate phenotypic characterization and evidence-based treatment selection difficult. ITACA is designed to address these gaps through systematic real-world data collection in a multicenter setting.
The study is a prospective, multicenter, observational longitudinal cohort conducted in routine outpatient clinical practice. Recruitment is planned for 3 years, with follow-up for up to 3 years per participant and an overall study duration of approximately 6 years. Consecutive eligible adult outpatients with a diagnosis of cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua according to ICHD-3 will be invited to participate. Relevant pre-enrollment clinical information already available in medical records may be collected retrospectively at baseline to improve characterization of disease history.
No protocol-mandated treatment or investigational intervention is assigned. Acute and preventive treatments are prescribed independently by treating physicians according to routine clinical practice. Data are collected at baseline and at routine follow-up visits, expected approximately every 3-6 months or whenever clinically indicated. Collected information includes attack frequency, duration and severity, cranial autonomic and other accompanying symptoms, temporal patterns, disease course, treatment history and ongoing treatment exposure, treatment effectiveness and tolerability, adverse events, comorbidities, lifestyle factors, concomitant medications, headache diary information, and patient-reported measures. Questionnaires may include PGIC, ASC-12, EQ-5D, SF-36, CHIQ, HARS, HDRS, HADS, LDQ, and PSQI according to routine practice and local availability. Data are recorded in a standardized electronic case report form using REDCap.
The planned sample size is approximately 800 participants, expected to include about 70-80% with cluster headache and 20-30% with other trigeminal autonomic cephalalgias. Analyses will be primarily descriptive and will include longitudinal and multivariable models to assess clinical characteristics, treatment outcomes, and predictors of response, refractoriness, and disease progression.
- 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
- Medical subject headings
- Trigeminal Autonomic Cephalalgias, Cluster Headache, Paroxysmal Hemicrania
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Number of participants initiating a new preventive treatment
Number and percentage of participants who initiate a new preventive treatment during follow-up.
Measured: 3 years
Number of participants switching preventive treatment
Number and percentage of participants who switch from one preventive treatment to another during follow-up.
Measured: 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.
Measured: 3 years
Duration of preventive treatment retention
Time from initiation of a preventive treatment to permanent discontinuation of that treatment, expressed in months.
Measured: 3 years
Secondary outcomes (27)
Change from baseline in weekly attack frequency during preventive treatment
Change in the number of headache attacks per week from the pretreatment baseline value during preventive treatment.
Measured: 3 years
Number of participants achieving at least a 50% reduction in weekly attack frequency
Number and percentage of participants with a reduction of at least 50% in weekly attack frequency compared with the pretreatment baseline value.
Measured: 3 years
Change from baseline in days per week requiring acute headache medication
Change in the number of days per week on which acute headache medication is used compared with the pretreatment baseline value.
Measured: 3 years
Number of participants achieving sustained attack remission
Number and percentage of participants experiencing at least 3 consecutive months without headache attacks.
Measured: 3 years
Number of participants experiencing adverse events during preventive treatment
Number and percentage of participants with one or more adverse events occurring during exposure to preventive treatment. Adverse-event type and frequency will be summarized by treatment where available.
Measured: 3 years
Number of participants experiencing serious adverse events during preventive treatment
Number and percentage of participants with one or more serious adverse events occurring during exposure to preventive treatment.
Measured: 3 years
Number of participants discontinuing preventive treatment because of adverse events
Number and percentage of participants who permanently discontinue a preventive treatment because of an adverse event.
Measured: 3 years
Number of participants achieving pain freedom 15 minutes after acute treatment of the first treated attack
Number and percentage of participants with absence of headache pain 15 minutes after administration of acute treatment for the first prospectively assessed treated attack.
Measured: 3 years
Proportion of consecutively treated attacks with pain freedom 15 minutes after acute treatment
Proportion of up to four consecutive treated attacks in which pain freedom is achieved 15 minutes after administration of acute treatment.
Measured: 3 years
Number of participants achieving pain relief 15 minutes after acute treatment
Number and percentage of participants meeting the study definition of pain relief 15 minutes after administration of acute treatment.
Measured: 3 years
Number of participants achieving pain relief 2 hours after acute treatment
Number and percentage of participants meeting the study definition of pain relief 2 hours after administration of acute treatment.
Measured: 3 years
Functional Disability Scale score 15 minutes after acute treatment
Functional status 15 minutes after administration of acute treatment, assessed using the Functional Disability Scale specified in the study.
Measured: 3 years
Functional Disability Scale score 2 hours after acute treatment
Functional status 2 hours after administration of acute treatment, assessed using the Functional Disability Scale specified in the study.
Measured: 3 years
Number of participants with headache recurrence within 12 hours after initial pain freedom
Among participants who achieve initial pain freedom after acute treatment, number and percentage with recurrence of headache within 12 hours.
Measured: 3 years
Number of participants experiencing adverse events following acute treatment
Number and percentage of participants with one or more adverse events occurring in association with acute treatment.
Measured: 3 years
Number of participants experiencing serious adverse events following acute treatment
Number and percentage of participants with one or more serious adverse events occurring in association with acute treatment.
Measured: 3 years
Number of participants discontinuing an acute treatment because of adverse events
Number and percentage of participants who discontinue use of an acute treatment because of an adverse event.
Measured: 3 years
PGIC score
Patients impression of change after treatment initiation
Measured: 3 years
Change from baseline in ASC-12 score
Measured: 3 years
Change from baseline in EQ-5D measure
Measured: 3 years
Change from baseline in SF-36 score
Measured: 3 years
Change from baseline in CHIQ score
Measured: 3 years
Change from baseline in HARS score
Measured: 3 years
Change from baseline in HDRS score
Measured: 3 years
Change from baseline in HADS score
Measured: 3 years
Change from baseline in modified LDQ score
Measured: 3 years
Change from baseline in PSQI score
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Sep 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal Autonomic CephalalgiasStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Licia Grazzi, MD, Principal investigator, Fondazione IRCCS Istituto Neurologico C. Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812740
- Sponsor's protocol ID
- ITACA
- Acronym
- ITACA
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Trigeminal Autonomic Cephalalgias Assessment Study (ITACA)
- ClinicalTrials.gov ID
- NCT07812740
- Acronym / sponsor ID
- ITACA / ITACA
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- 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
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trigeminal autonomic cephalalgias are rare and highly disabling primary headache disorders characterized by unilateral pain and ipsilateral cranial autonomic symptoms. Their clinical heterogeneity, frequent misdiagnosis, diagnostic delay, and the limited availability of large longitudinal datasets make accurate phenotypic characterization and evidence-based treatment selection difficult. ITACA is designed to address these gaps through systematic real-world data collection in a multicenter setting.
The study is a prospective, multicenter, observational longitudinal cohort conducted in routine outpatient clinical practice. Recruitment is planned for 3 years, with follow-up for up to 3 years per participant and an overall study duration of approximately 6 years. Consecutive eligible adult outpatients with a diagnosis of cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua according to ICHD-3 will be invited to participate. Relevant pre-enrollment clinical information already available in medical records may be collected retrospectively at baseline to improve characterization of disease history.
No protocol-mandated treatment or investigational intervention is assigned. Acute and preventive treatments are prescribed independently by treating physicians according to routine clinical practice. Data are collected at baseline and at routine follow-up visits, expected approximately every 3-6 months or whenever clinically indicated. Collected information includes attack frequency, duration and severity, cranial autonomic and other accompanying symptoms, temporal patterns, disease course, treatment history and ongoing treatment exposure, treatment effectiveness and tolerability, adverse events, comorbidities, lifestyle factors, concomitant medications, headache diary information, and patient-reported measures. Questionnaires may include PGIC, ASC-12, EQ-5D, SF-36, CHIQ, HARS, HDRS, HADS, LDQ, and PSQI according to routine practice and local availability. Data are recorded in a standardized electronic case report form using REDCap.
The planned sample size is approximately 800 participants, expected to include about 70-80% with cluster headache and 20-30% with other trigeminal autonomic cephalalgias. Analyses will be primarily descriptive and will include longitudinal and multivariable models to assess clinical characteristics, treatment outcomes, and predictors of response, refractoriness, and disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline and routine follow-up visits through 3 years after enrollment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 years
Number and percentage of participants who initiate a new preventive treatment during follow-up.
Number of participants switching preventive treatment
Time frame: 3 years
Number and percentage of participants who switch from one preventive treatment to another during follow-up.
Number of participants discontinuing preventive treatment
Time frame: 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
Time frame: 3 years
Time from initiation of a preventive treatment to permanent discontinuation of that treatment, expressed in months.
27 secondary outcomes
Change from baseline in weekly attack frequency during preventive treatment
Time frame: 3 years
Number of participants achieving at least a 50% reduction in weekly attack frequency
Time frame: 3 years
Change from baseline in days per week requiring acute headache medication
Time frame: 3 years
Number of participants achieving sustained attack remission
Time frame: 3 years
Number of participants experiencing adverse events during preventive treatment
Time frame: 3 years
Number of participants experiencing serious adverse events during preventive treatment
Time frame: 3 years
Number of participants discontinuing preventive treatment because of adverse events
Time frame: 3 years
Number of participants achieving pain freedom 15 minutes after acute treatment of the first treated attack
Time frame: 3 years
Proportion of consecutively treated attacks with pain freedom 15 minutes after acute treatment
Time frame: 3 years
Number of participants achieving pain relief 15 minutes after acute treatment
Time frame: 3 years
Number of participants achieving pain relief 2 hours after acute treatment
Time frame: 3 years
Functional Disability Scale score 15 minutes after acute treatment
Time frame: 3 years
Functional Disability Scale score 2 hours after acute treatment
Time frame: 3 years
Number of participants with headache recurrence within 12 hours after initial pain freedom
Time frame: 3 years
Number of participants experiencing adverse events following acute treatment
Time frame: 3 years
Number of participants experiencing serious adverse events following acute treatment
Time frame: 3 years
Number of participants discontinuing an acute treatment because of adverse events
Time frame: 3 years
PGIC score
Time frame: 3 years
Change from baseline in ASC-12 score
Time frame: 3 years
Change from baseline in EQ-5D measure
Time frame: 3 years
Change from baseline in SF-36 score
Time frame: 3 years
Change from baseline in CHIQ score
Time frame: 3 years
Change from baseline in HARS score
Time frame: 3 years
Change from baseline in HDRS score
Time frame: 3 years
Change from baseline in HADS score
Time frame: 3 years
Change from baseline in modified LDQ score
Time frame: 3 years
Change from baseline in PSQI score
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Licia Grazzi, MD principal investigator
Fondazione IRCCS Istituto Neurologico C. Besta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Autonomic Cephalalgias and Cluster Headache, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Licia Grazzi, MD (+ 02 2394, licia.grazzi@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline and routine follow-up visits through 3 years after enrollment (time frame: 3 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.