(Italian Migraine Registry, I-GRAINE-NEW)

NCT ID: NCT07163416

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2030 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2026-03-05

Brief 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. 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

Conditions

Migraine Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patients affected by other forms of primary or secondary headaches or in whom the diagnosis is not certain

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Piero Barbanti, MD

Role: CONTACT

piero.barbanti@sanraffaele.it

+390652254027

Facility Contacts

Piero NA Barbante, Degree in Medicine and Surgery

Role: primary

piero.barbanti@sanraffaele.it

+39 0652254027

Gabriella Egeo, Degree in Medicine and Surgery

Role: backup

gabriella.egeo@sanraffaele.it

+39 0652254027

Other Identifiers

RP 20/16

Identifier Type: -

Identifier Source: org_study_id