Migraine DisordersI-GRAINE-NEWNCT07163416
(Italian Migraine Registry, I-GRAINE-NEW)
An observational study of Migraine Disorders, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic "evolutionary" condition. Patients often come to migraine centers after years of disabling disease, non-specific diagnoses and ineffective treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders
- How many people
- 2,030 participants
- Where
- 1 siteItaly
- Study dates
- 19 Apr 2021to 5 Dec 2026
- How long will I take part?
- 5 Years
- 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: The reference population for the registry IGRAINE includes adult patients of both sexes, suffering from episodic or chronic migraine, undergoing treatment at a specialized headache center. At the time of its launch, 46 headache centers distributed throughout Italy will participate in the registry. To ensure its representativeness, the study sample includes 10% of the total number of patients followed at the centers, selected randomly. The registry will be enrolled using the "systematic random" method. Participation in the study will be offered to the first patient at the first visit (incident patient) and to the first patient at the follow-up visit (prevalent patient) of each outpatient day at the clinical center. If the first patient in each category refuses, participation in the study will be offered to the next patient in order of visit in the same category (prevalent or incident). Researchers are advised NOT to skip patients so as not to create a selection bias in the population.
Who may be able to join
- Adult Patients(Age ≥ 18 years) of both sexes
- Diagnosis confirmed of episodic migraine ( <15 days/month ) with or without aura or chronic migraine (>15days/month) ,with or without headeche due to overuse of analgesics;
- Provision of signed and dated the Informed Consent Form before the inclusion in the study
Who cannot join
- Patients affected by other forms of primary or secondary headaches or in whom the diagnosis is not certain
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
Head, Irccs San Raffaele Roma S.r.l. - Unità per la cura e la ricerca su cefalee e dolore - Dipartimento di Neurologia, Via di Val di Cannuta 250, 00166 Roma (RM) - Italy
Roma, Roma, 00166
Piero NA Barbante, Degree in Medicine and Surgery, +39 0652254027, piero.barbanti@sanraffaele.it
Gabriella Egeo, Degree in Medicine and Surgery, +39 0652254027, gabriella.egeo@sanraffaele.it
About this study
Official title: Project for the Construction of the Italian Migraine Registry I-GRAINE-New
Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic "evolutionary" condition. Patients often come to migraine centers after years of disabling disease, non-specific diagnoses and ineffective treatments. When patients are admitted to the center is therefore the time when their history in terms of disease evolution and healthcare costs is most effectively collected, but also when it is assumed that the treatment strategy offered to the patient will have a greater impact.
For this reason, it was decided to conduct a large-scale retrospective and prospective observational study in order to draw a detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.
Read more
Design A multicenter, observational, retrospective and prospective cohort study, aimed at obtaining a more detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.6,000 of the incident patients (defined as those who had their first visit during the 6 months preceding enrollment in the registry), will be invited to take part in a follow-up and expanded data collection study.
Patients will be consecutively enrolled by specialists at each individual site.. Eligible patients who agree to take part in the study by signing an informed consent form will be assessed clinically and through a direct interview with a structured questionnaire organized in several ad hoc sections.
Objectives: The aim of the study is:
analyze episodic and chronic migraine in Italy from an epidemiological point of view, especially in terms of prevalence of the two forms of migraine and their endophenotypes in different population subgroups; 2. characterize the demographic distribution and clinical characteristics of patients (including the definition of endophenotypes); 3. measure the influence of the disease on the patient's daily activity, in terms of disability (assessed using the validated MIDAS and HIT-6 scales); 4. study the clinical and care pathway (patient journey) and identify the preferred care pathways based on the characteristics of the patients and the migraine subtype; 5. evaluate the prescribed pharmacological treatments, medical visits and diagnostic procedures performed (ascertaining the degree of adherence to current guidelines); 6. analyze the use of health resources by migraine patients, with particular attention to their impact on the SNS.
Visits and Treatments:
Baseline Visit: Patients enrolled in the study will undergo a thorough clinical and neurological examination.
Follow-up Visits: Clinical data will continue to be collected over time, at each scheduled clinic visit based on the needs of clinical practice.
Study Population: Adult patients of both sexes with episodic or chronic migraine who have recently attended a specialized migraine center in the I-GRAINE-NEW registry.
Estimated Study Duration: The duration of each patient's participation in the study is 24 months from the date of the initial visit to the participating migraine site
- Conditions
- Migraine Disorders
- Keywords
- Migraine,Register,Italy
- Medical subject headings
- Migraine Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Better definition of the dimensions of the migraine phenomenon in Italian headache centers
More appropriate estimate of the prevalence of migraines refractory to treatments.
In particular:
1.Identification of clinical endophenotypes that can be predictive of evolution and pharmacological .
Allodynia will be assessed through the ASC 12 scale.
- Disability measured using the validated clinical scales MIDAS, HIT-6.
- Treatments for migraine attacks and preventive therapies
Measured: "Baseline visit or (day 1)"" through study completion, an average of 2 year"
Information on the patient's level of awareness and knowledge of the migraine problem
- Information on the times and methods of access to treatments:
- evaluation of the interval between the onset of the pathology and access to medical care;
- health tourism (migration of patients to regions other than their own). 5. Critical issues of the current clinical governance and determination of the use of healthcare resources, and in particular:
- Presence or absence of regional PDTA b. Degree of adherence to diagnostic-therapeutic guidelines c. Proper or improper use of diagnostic tests d. Patient traceability e. Definition of the percentage of patients who access visits, tests and treatments through the NHS.
Measured: Baseline visit ,through study completion, an average of 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start19 Apr 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,030 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163416
- Sponsor's protocol ID
- RP 20/16
- Acronym
- I-GRAINE-NEW
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project for the Construction of the Italian Migraine Registry I-GRAINE-New
- ClinicalTrials.gov ID
- NCT07163416
- Acronym / sponsor ID
- I-GRAINE-NEW / RP 20/16
- Conditions
- Migraine Disorders
- Keywords
- Migraine,Register,Italy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,030 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 9 Sep 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.
Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic "evolutionary" condition. Patients often come to migraine centers after years of disabling disease, non-specific diagnoses and ineffective treatments. When patients are admitted to the center is therefore the time when their history in terms of disease evolution and healthcare costs is most effectively collected, but also when it is assumed that the treatment strategy offered to the patient will have a greater impact.
For this reason, it was decided to conduct a large-scale retrospective and prospective observational study in order to draw a detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.
Design A multicenter, observational, retrospective and prospective cohort study, aimed at obtaining a more detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.6,000 of the incident patients (defined as those who had their first visit during the 6 months preceding enrollment in the registry), will be invited to take part in a follow-up and expanded data collection study.
Patients will be consecutively enrolled by specialists at each individual site.. Eligible patients who agree to take part in the study by signing an informed consent form will be assessed clinically and through a direct interview with a structured questionnaire organized in several ad hoc sections.
Objectives: The aim of the study is:
analyze episodic and chronic migraine in Italy from an epidemiological point of view, especially in terms of prevalence of the two forms of migraine and their endophenotypes in different population subgroups; 2. characterize the demographic distribution and clinical characteristics of patients (including the definition of endophenotypes); 3. measure the influence of the disease on the patient's daily activity, in terms of disability (assessed using the validated MIDAS and HIT-6 scales); 4. study the clinical and care pathway (patient journey) and identify the preferred care pathways based on the characteristics of the patients and the migraine subtype; 5. evaluate the prescribed pharmacological treatments, medical visits and diagnostic procedures performed (ascertaining the degree of adherence to current guidelines); 6. analyze the use of health resources by migraine patients, with particular attention to their impact on the SNS.
Visits and Treatments:
Baseline Visit: Patients enrolled in the study will undergo a thorough clinical and neurological examination.
Follow-up Visits: Clinical data will continue to be collected over time, at each scheduled clinic visit based on the needs of clinical practice.
Study Population: Adult patients of both sexes with episodic or chronic migraine who have recently attended a specialized migraine center in the I-GRAINE-NEW registry.
Estimated Study Duration: The duration of each patient's participation in the study is 24 months from the date of the initial visit to the participating migraine site
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The reference population for the registry IGRAINE includes adult patients of both sexes, suffering from episodic or chronic migraine, undergoing treatment at a specialized headache center. At the time of its launch, 46 headache centers distributed throughout Italy will participate in the registry. To ensure its representativeness, the study sample includes 10% of the total number of patients followed at the centers, selected randomly. The registry will be enrolled using the "systematic random" method. Participation in the study will be offered to the first patient at the first visit (incident patient) and to the first patient at the follow-up visit (prevalent patient) of each outpatient day at the clinical center. If the first patient in each category refuses, participation in the study will be offered to the next patient in order of visit in the same category (prevalent or incident). Researchers are advised NOT to skip patients so as not to create a selection bias in the population.
Key inclusion criteria (3 listed)
- Adult Patients(Age ≥ 18 years) of both sexes
- Diagnosis confirmed of episodic migraine ( <15 days/month ) with or without aura or chronic migraine (>15days/month) ,with or without headeche due to overuse of analgesics;
- Provision of signed and dated the Informed Consent Form before the inclusion in the study
Key exclusion criteria (1 listed)
- Patients affected by other forms of primary or secondary headaches or in whom the diagnosis is not certain
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
Better definition of the dimensions of the migraine phenomenon in Italian headache centers
Time frame: "Baseline visit or (day 1)"" through study completion, an average of 2 year"
More appropriate estimate of the prevalence of migraines refractory to treatments. In particular: 1.Identification of clinical endophenotypes that can be predictive of evolution and pharmacological . Allodynia will be assessed through the ASC 12 scale. 1. Disability measured using the validated clinical scales MIDAS, HIT-6. 2. Treatments for migraine attacks and preventive therapies
Information on the patient's level of awareness and knowledge of the migraine problem
Time frame: Baseline visit ,through study completion, an average of 2year
1. Information on the times and methods of access to treatments: 1. evaluation of the interval between the onset of the pathology and access to medical care; 2. health tourism (migration of patients to regions other than their own). 5. Critical issues of the current clinical governance and determination of the use of healthcare resources, and in particular: a. Presence or absence of regional PDTA b. Degree of adherence to diagnostic-therapeutic guidelines c. Proper or improper use of diagnostic tests d. Patient traceability e. Definition of the percentage of patients who access visits, tests and treatments through the NHS.
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 20 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.
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 Disorders, run by IRCCS San Raffaele Roma 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 1 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 20 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?
Contact Piero Barbanti, MD (+390652254027, piero.barbanti@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Better definition of the dimensions of the migraine phenomenon in Italian headache centers (time frame: "Baseline visit or (day 1)"" through study completion, an average of 2 year"). 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 20 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.