Actively Recruiting

Age: 18Years +
All Genders
ID07163416

Project for the Construction of the Italian Migraine Registry I-GRAINE-New

Led by IRCCS San Raffaele Roma · Updated on 2025-09-09

2030

Participants Needed

1

Research Sites

11 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a large-scale observational study called the Italian Migraine Registry I-GRAINE-New to better understand migraine disorders. The study focuses on adults with episodic or chronic migraine who have recently visited specialized migraine centers. It aims to analyze the prevalence and characteristics of migraine types, the impact on daily life, treatment patterns, and healthcare resource use in Italy. This study involves enrolling patients consecutively at multiple centers, where they undergo a detailed clinical and neurological examination at baseline. Follow-up data will be collected during routine clinic visits over an average of two years to observe the natural history and care pathways of migraine once patients start specialist treatment. Participants will be assessed through clinical exams and structured interviews, including validated scales like MIDAS and HIT-6, to measure disability and disease influence. The study measures the size and awareness of the migraine problem in headache centers and tracks patients' treatment and healthcare use. Each patient's participation lasts about 24 months from their initial visit to the migraine center.

CONDITIONS

Brief Title

(Italian Migraine Registry, I-GRAINE-NEW)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Diagnosis confirmed of episodic migraine (less than 15 days per month) with or without aura or chronic migraine (more than 15 days per month), with or without headache due to overuse of analgesics
  • Signed and dated informed consent form provided before study inclusion
Not Eligible

You will not qualify if you...

  • Patients with other forms of primary or secondary headaches or uncertain diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Baseline Visit

Duration - Day 1

Participants attend a baseline visit to provide initial information and assessments about their migraine condition.

1 visit (in-person)

Long-term Monitoring

Duration - Approximately 2 years

Participants are observed over an average of 2 years to better define the migraine phenomenon and assess their awareness and knowledge of the migraine problem.

Follow-up visits through study completion

Trial Site Locations

Total: 1 location

1

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, 00166

Actively Recruiting

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Research Team

P

Piero Barbanti, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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