Italian Migraine Registry (I-GRAINE-NEW)
Official title: Project for the Construction of the Italian Migraine Registry I-GRAINE-New
Run by IRCCS San Raffaele Roma · NCT07163416 · Data updated 2026-11-12
This registry will collect past and future clinical and healthcare data from adults with episodic or chronic migraine who come to specialized headache centers in Italy to better understand how the condition evolves and is treated.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2030 (estimated) |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Roma, Roma) |
| Status | Recruiting |
| Started | April 19, 2021 |
| Main results expected | December 1, 2026 |
| Study ends | December 5, 2026 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07163416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a confirmed diagnosis of episodic (fewer than 15 days/month) or chronic migraine (more than 15 days/month), with or without medication overuse, who can give informed consent are ideal candidates.
✕Probably not a fit
Patients with other primary or secondary headache disorders or with an uncertain migraine diagnosis are unlikely to benefit from participation in this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
I-GRAINE-NEW is a multicenter observational cohort that combines retrospective chart review with prospective follow-up to map the natural history and care pathways of migraine patients entering specialized centers. The project will collect demographic, clinical, treatment history, and healthcare utilization data at baseline and during follow-up visits. Inclusion targets adults diagnosed with episodic or chronic migraine, including those with medication overuse, who provide informed consent. No experimental treatments are given as part of the registry; data are used to describe real-world disease evolution and management.
Why it matters
Potential benefit: If successful, the registry could help clinicians tailor care and health systems allocate resources by revealing typical disease courses and treatment gaps for migraine patients in Italy.
How similar studies have gone: Other national and regional migraine registries and observational cohorts have provided useful insights into epidemiology, treatment patterns, and care gaps, though comprehensive national longitudinal data remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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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 Recruiting
Study contacts
- Study coordinator: Piero Barbanti, MD
- Email: piero.barbanti@sanraffaele.it
- Phone: +390652254027
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.