Italian Migraine Registry (I-GRAINE-NEW)
Project for the Construction of the Italian Migraine Registry I-GRAINE-New
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 |
|---|---|
| Enrollment | 2030 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Roma, Roma) |
| Trial ID | NCT07163416 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, Roma
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.