MigraineTIARANCT06891053
Studio TIARA: Alessitimia ed Emicrania Cronica
An observational study of Migraine and Alexithymia, run by Azienda Sanitaria Locale di Alessandria at 1 site in Italy.
Trial summary
The aim of this observational, cross-sectional study is to investigate the relationship between alexithymia and migraine frequency (considering alexithymia a condition that can influence the severity of the clinical phenotype of migraine, favoring its chronicization), in an analysis adjusted for psychiatric… Read more about this study
- Who is it for?
- Ages 12 to 65 years, women only
- Conditions the study is for
- Migraine, Alexithymia
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2022to 31 Dec 2027
- 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 12 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients, aged 12-65 years, diagnosed with episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria
Who may be able to join
- Diagnosis of episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria;
- Patients aged 12-65 years;
- Female patients
Who cannot join
- Ongoing major depressive episode;
- Comorbidities for major internal diseases (hepatopathy, nephropathy, heart failure, etc.);
- Alcohol or substance abuse disorder (eoin, cocaine, cannabis, hallucinogens);
- Language barrier;
- Low cultural/cognitive level;
- No informed consent.
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
Azienda Sanitaria Locale di Alessandria (ASL AL)
Alessandria, Italy, 15121
About this study
The aim of this observational, cross-sectional study is to investigate the relationship between alexithymia and migraine frequency (considering alexithymia a condition that can influence the severity of the clinical phenotype of migraine, favoring its chronicization), in an analysis adjusted for psychiatric comorbidity (for anxiety and depression, potentially influencing migraine chronicization) and for personalogical factor represented by apathy.
- Conditions
- Migraine, Alexithymia
- Medical subject headings
- Migraine Disorders, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of episodic migraine without or with aura, chronic migraine, and/or MOH | Female patients, aged 12-65 years, diagnosed with episodic migraine without or with aura, chronic migraine, and/or MOH according to the criteria of ICHD-3 2018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of alexithymia
Independent variable measured as a score on the TAS-20 scale
Measured: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Migraine frequency
Measured: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Secondary outcomes (2)
Number of "drug days" in patients diagnosed with MOH
Measured: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Degree of alessithymia in patients diagnosed with MOH
Measured: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start30 May 2022
- Primary completionJun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugenia Rota, Principal investigator, Azienda Sanitaria Locale di Alessandria (ASL AL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891053
- Sponsor's protocol ID
- Asl22.Neuro.22.01
- Acronym
- TIARA
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2025
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio TIARA: Alessitimia ed Emicrania Cronica
- ClinicalTrials.gov ID
- NCT06891053
- Acronym / sponsor ID
- TIARA / Asl22.Neuro.22.01
- Conditions
- Migraine, Alexithymia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale di AlessandriaUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Mar 2025 (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.
The aim of this observational, cross-sectional study is to investigate the relationship between alexithymia and migraine frequency (considering alexithymia a condition that can influence the severity of the clinical phenotype of migraine, favoring its chronicization), in an analysis adjusted for psychiatric comorbidity (for anxiety and depression, potentially influencing migraine chronicization) and for personalogical factor represented by apathy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis of episodic migraine without or with aura, chronic migraine, and/or MOH | – | –Female patients, aged 12-65 years, diagnosed with episodic migraine without or with aura, chronic migraine, and/or MOH according to the criteria of ICHD-3 2018 |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients, aged 12-65 years, diagnosed with episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria
Key inclusion criteria (3 listed)
- Diagnosis of episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria;
- Patients aged 12-65 years;
- Female patients
Key exclusion criteria (6 listed)
- Ongoing major depressive episode;
- Comorbidities for major internal diseases (hepatopathy, nephropathy, heart failure, etc.);
- Alcohol or substance abuse disorder (eoin, cocaine, cannabis, hallucinogens);
- Language barrier;
- Low cultural/cognitive level;
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
Degree of alexithymia
Time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Independent variable measured as a score on the TAS-20 scale
Migraine frequency
Time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
2 secondary outcomes
Number of "drug days" in patients diagnosed with MOH
Time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Degree of alessithymia in patients diagnosed with MOH
Time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
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 28 Oct 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.
Eugenia Rota principal investigator
Azienda Sanitaria Locale di Alessandria (ASL AL)
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 Migraine and Alexithymia, run by Azienda Sanitaria Locale di Alessandria 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 3 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 28 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of alexithymia (time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval). The study lists 2 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 28 Oct 2026.