Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Migraine Disorders trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2030 (estimated)
SponsorIRCCS San Raffaele Roma
Academic / other
Locations1 site (Roma, Roma)
StatusRecruiting
StartedApril 19, 2021
Main results expectedDecember 1, 2026
Study endsDecember 5, 2026
Registry record updatedOctober 20, 2026
Trial IDNCT07163416 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.